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Clinical Trial Results:
HIGH DOSE SUPPLEMENTATION OF SELENIUM IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT SURGERY – A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL

Summary
EudraCT number	2013-001357-26
Trial protocol	DE
Global end of trial date	07 Sep 2017
Results information
Results version number	v1(current)
This version publication date	06 Feb 2022
First version publication date	06 Feb 2022
Other versions

Trial information Top of page
Trial identification
Sponsor protocol code	13-036
Additional study identifiers
ISRCTN number	-
US NCT number	NCT02530788
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Universitätsklinikum RWTH Aachen
Sponsor organisation address	Pauwelsstraße 30, Aachen, Germany, 52074
Public contact	Center for Translational & Clinical Research Aachen (CTC-A), University RWTH Aachen, 49 2418080092, ctc-a-spoqs@ukaachen.de
Scientific contact	Center for Translational & Clinical Research Aachen (CTC-A), University RWTH Aachen, 49 2418080092, ctc-a-spoqs@ukaachen.de
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	07 Apr 2021
Is this the analysis of the primary completion data?	Yes
Primary completion date	07 Sep 2017
Global end of trial reached?	Yes
Global end of trial date	07 Sep 2017
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To determine the effects and safety of Selenium supplementation on postoperative recovery after LVAD implant surgery.
Protection of trial subjects	This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	25 Aug 2015
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Germany: 21
Worldwide total number of subjects	21
EEA total number of subjects	21
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	11
From 65 to 84 years	10
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Recruitment and treatment of subjects was performed in one trial center. Overall 21 subjects were enrolled and randomized in the clinical trial in the timeframe from 25.08.2015 till 07.09.2017.
Pre-assignment
Screening details	Overall 21 subjects were screened in one trial center. Of those 21 subjects screened, all 21 subjects met the inclusion and exclusion criteria and were enrolled and randomized in the clinical trial.
Period 1
Period 1 title	evening before surgery
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 1 Selenase Placebo Started 11 10 Completed 11 10
Period 2
Period 2 title	ICU release or post-operative day 30
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 2 Selenase Placebo Started 11 10 Completed 11 10
Period 3
Period 3 title	Post-operative day 7
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 3 Selenase Placebo Started 11 10 Completed 11 10
Period 4
Period 4 title	Post-operative day 28
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 4 Selenase Placebo Started 11 10 Completed 11 10
Period 5
Period 5 title	Day 0
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 5 Selenase Placebo Started 11 10 Completed 11 10
Period 6
Period 6 title	Day 1
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 6 Selenase Placebo Started 11 10 Completed 11 10
Period 7
Period 7 title	Day 2
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 7 Selenase Placebo Started 11 10 Completed 11 10
Period 8
Period 8 title	Day 3
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 8 Selenase Placebo Started 11 10 Completed 11 10
Period 9
Period 9 title	Day 4
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 9 Selenase Placebo Started 11 10 Completed 11 10
Period 10
Period 10 title	Day 5
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 10 Selenase Placebo Started 11 10 Completed 11 10
Period 11
Period 11 title	Day 6
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 11 Selenase Placebo Started 11 10 Completed 11 10
Period 12
Period 12 title	Day 7
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 12 Selenase Placebo Started 11 10 Completed 11 10
Period 13
Period 13 title	Day 8
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 13 Selenase Placebo Started 11 10 Completed 11 10
Period 14
Period 14 title	Day 9
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 14 Selenase Placebo Started 11 10 Completed 11 10
Period 15
Period 15 title	Day 10
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 15 Selenase Placebo Started 11 10 Completed 11 10
Period 16
Period 16 title	Day 11
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 16 Selenase Placebo Started 11 10 Completed 11 10
Period 17
Period 17 title	Day 12
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 17 Selenase Placebo Started 11 10 Completed 11 10
Period 18
Period 18 title	Day 13
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 18 Selenase Placebo Started 11 10 Completed 11 10
Period 19
Period 19 title	Day 14
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 19 Selenase Placebo Started 11 10 Completed 11 10
Period 20
Period 20 title	Day 15
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 20 Selenase Placebo Started 11 10 Completed 11 10
Period 21
Period 21 title	Day 16
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 21 Selenase Placebo Started 11 10 Completed 11 10
Period 22
Period 22 title	Day 17
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 22 Selenase Placebo Started 11 10 Completed 11 10
Period 23
Period 23 title	Day 18
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 23 Selenase Placebo Started 11 10 Completed 11 10
Period 24
Period 24 title	Day 19
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 24 Selenase Placebo Started 11 10 Completed 11 10
Period 25
Period 25 title	Day 20
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 25 Selenase Placebo Started 11 10 Completed 11 10
Period 26
Period 26 title	Day 21
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 26 Selenase Placebo Started 11 10 Completed 11 10
Period 27
Period 27 title	Day 22
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Investigator, Subject
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 27 Selenase Placebo Started 11 10 Completed 11 10
Period 28
Period 28 title	Day 23
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Investigator, Subject
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 28 Selenase Placebo Started 11 10 Completed 11 10
Period 29
Period 29 title	Day 24
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 29 Selenase Placebo Started 11 10 Completed 11 10
Period 30
Period 30 title	Day 25
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 30 Selenase Placebo Started 11 10 Completed 11 10
Period 31
Period 31 title	Day 26
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 31 Selenase Placebo Started 11 10 Completed 11 10
Period 32
Period 32 title	Day 27
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 32 Selenase Placebo Started 11 10 Completed 11 10
Period 33
Period 33 title	Day 28
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 33 Selenase Placebo Started 11 10 Completed 11 10
Period 34
Period 34 title	Day 29
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 34 Selenase Placebo Started 11 10 Completed 11 10
Period 35
Period 35 title	Day 30
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	Yes
Arm title	Selenase
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Selen
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once 300 µg orally on evening before surgery
Investigational medicinal product name	selenase T pro injectione
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once 3000 µg intravenous bolusinfusion while surgery, daily 1000 µg intravenous bolusinfusion post surgery (maximum till post operative day 13)
Arm title	Placebo
Arm description	-
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	once orally on evening before surgery
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Infusion
Routes of administration	Intravenous use
Dosage and administration details	once intravenous bolusinfusion while surgery, daily intranvenous bolusinfusion (maximum till post operative day 13)
Number of subjects in period 35 Selenase Placebo Started 11 10 Completed 11 10

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group values Selenase Placebo Total Number of subjects 11 10 21 Age categorical Units: Subjects     In utero 0     Preterm newborn infants (gestational age < 37 wks) 0     Newborns (0-27 days) 0     Infants and toddlers (28 days-23 months) 0     Children (2-11 years) 0     Adolescents (12-17 years) 0     Adults (18-64 years) 0     From 65-84 years 0     85 years and over 0 Age continuous Units: years     arithmetic mean (standard deviation) 63.82 ( 10.91 ) 61.5 ( 8.127 ) - Gender categorical Units: Subjects     Female 1 1 2     Male 10 9 19

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-

End points Top of page

Primary: Composite Outcome Top of page
End point title	Composite Outcome
End point description	ICU independency, independency of dialysis, circulatory support and ventilation
End point type	Primary
End point timeframe	from surgery till ICU release or post-operative day 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: days     median (inter-quartile range (Q1-Q3)) 214 (61 to 381) 117 (64 to 287)
Statistical analysis title	Analysis composite outcome
Comparison groups	Selenase v Placebo
Number of subjects included in analysis	21
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.89
Method	Kruskal-wallis
Confidence interval

Primary: Composite Outcome Top of page

Secondary: Mortality Top of page
End point title	Mortality
End point description
End point type	Secondary
End point timeframe	POD 28
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     alive 9 9     deceased 2 1
No statistical analyses for this end point

Secondary: Mortality Top of page

Secondary: Persistent Organ Disfunction Top of page
End point title	Persistent Organ Disfunction
End point description
End point type	Secondary
End point timeframe	POD 7
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     yes 8 3     no 3 7
No statistical analyses for this end point

Secondary: Persistent Organ Disfunction Top of page

Secondary: Incidence of nosocomial infections Top of page
End point title	Incidence of nosocomial infections
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     yes 5 5     no 6 5
No statistical analyses for this end point

Secondary: Incidence of nosocomial infections Top of page

Secondary: Acute renal failure Top of page
End point title	Acute renal failure
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     yes 3 0     no 8 10
No statistical analyses for this end point

Secondary: Acute renal failure Top of page

Secondary: Duration of mechanical ventialtion Top of page
End point title	Duration of mechanical ventialtion
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: hours     median (inter-quartile range (Q1-Q3)) 91 (27 to 311) 89 (34 to 267)
No statistical analyses for this end point

Secondary: Duration of mechanical ventialtion Top of page

Secondary: Invasive mechanical ventilation Top of page
End point title	Invasive mechanical ventilation
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     yes 7 7     no 4 3
No statistical analyses for this end point

Secondary: Invasive mechanical ventilation Top of page

Secondary: Incidence of postoperative delirium Top of page
End point title	Incidence of postoperative delirium
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: subjects     yes 3 1     no 8 9
No statistical analyses for this end point

Secondary: Incidence of postoperative delirium Top of page

Secondary: Duration of ICU stay Top of page
End point title	Duration of ICU stay
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: days     median (inter-quartile range (Q1-Q3)) 18 (13 to 31) 16 (13 to 21)
No statistical analyses for this end point

Secondary: Duration of ICU stay Top of page

Secondary: Duration of hospital stay Top of page
End point title	Duration of hospital stay
End point description
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 10 [1] 10 Units: days     median (inter-quartile range (Q1-Q3)) 35 (28 to 47) 37 (20 to 46)
Notes [1] - 1 missing data
No statistical analyses for this end point

Secondary: Duration of hospital stay Top of page

Secondary: Barthel index Top of page
End point title	Barthel index
End point description	Individual Quality of life
End point type	Secondary
End point timeframe	ICU release or POD 30
End point values Selenase Placebo Number of subjects analysed 11 10 Units: none     median (inter-quartile range (Q1-Q3)) 65 (0 to 85) 88 (69 to 95)
No statistical analyses for this end point

Secondary: Barthel index Top of page

Secondary: Bilirubin - Day 1 Top of page
End point title	Bilirubin - Day 1
End point description
End point type	Secondary
End point timeframe	Day 1
End point values Selenase Placebo Number of subjects analysed 11 10 Units: mg / dl     arithmetic mean (standard deviation) 0.7518 ( 0.3121 ) 0.7880 ( 0.5853 )
No statistical analyses for this end point

Secondary: Bilirubin - Day 1 Top of page

Secondary: Bilirubin - Day 2 Top of page
End point title	Bilirubin - Day 2
End point description
End point type	Secondary
End point timeframe	Day 2
End point values Selenase Placebo Number of subjects analysed 9 [2] 10 Units: mg / dl     arithmetic mean (standard deviation) 0.5489 ( 0.1990 ) 0.9680 ( 1.2054 )
Notes [2] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 2 Top of page

Secondary: Bilirubin - Day 3 Top of page
End point title	Bilirubin - Day 3
End point description
End point type	Secondary
End point timeframe	Day 3
End point values Selenase Placebo Number of subjects analysed 9 [3] 10 Units: mg / dl     arithmetic mean (standard deviation) 0.5222 ( 0.2107 ) 1.183 ( 1.316 )
Notes [3] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 3 Top of page

Secondary: Bilirubin - Day 4 Top of page
End point title	Bilirubin - Day 4
End point description
End point type	Secondary
End point timeframe	Day 4
End point values Selenase Placebo Number of subjects analysed 9 [4] 10 Units: mg / dl     arithmetic mean (standard deviation) 0.5778 ( 0.2538 ) 0.9780 ( 1.3872 )
Notes [4] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 4 Top of page

Secondary: Bilirubin - Day 5 Top of page
End point title	Bilirubin - Day 5
End point description
End point type	Secondary
End point timeframe	Day 5
End point values Selenase Placebo Number of subjects analysed 9 [5] 10 Units: mg / dl     arithmetic mean (standard deviation) 0.4656 ( 0.1538 ) 1.016 ( 1.583 )
Notes [5] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 5 Top of page

Secondary: Bilirubin - Day 6 Top of page
End point title	Bilirubin - Day 6
End point description
End point type	Secondary
End point timeframe	Day 6
End point values Selenase Placebo Number of subjects analysed 9 [6] 10 Units: mg / dl     arithmetic mean (standard deviation) 0.4278 ( 0.1796 ) 0.7810 ( 1.1563 )
Notes [6] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 6 Top of page

Secondary: Bilirubin - Day 7 Top of page
End point title	Bilirubin - Day 7
End point description
End point type	Secondary
End point timeframe	Day 7
End point values Selenase Placebo Number of subjects analysed 9 [7] 9 [8] Units: mg / dl     arithmetic mean (standard deviation) 0.4289 ( 0.1997 ) 0.7833 ( 1.2007 )
Notes [7] - 2 missing data [8] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 7 Top of page

Secondary: Bilirubin - Day 8 Top of page
End point title	Bilirubin - Day 8
End point description
End point type	Secondary
End point timeframe	Day 8
End point values Selenase Placebo Number of subjects analysed 9 [9] 9 [10] Units: mg / dl     arithmetic mean (standard deviation) 0.3756 ( 0.1991 ) 0.6956 ( 0.9717 )
Notes [9] - 2 missing data [10] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 8 Top of page

Secondary: Bilirubin - Day 9 Top of page
End point title	Bilirubin - Day 9
End point description
End point type	Secondary
End point timeframe	Day 9
End point values Selenase Placebo Number of subjects analysed 7 [11] 9 [12] Units: mg / dl     arithmetic mean (standard deviation) 0.4171 ( 0.2127 ) 0.6822 ( 1.0344 )
Notes [11] - 4 missing data [12] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 9 Top of page

Secondary: Bilirubin - Day 10 Top of page
End point title	Bilirubin - Day 10
End point description
End point type	Secondary
End point timeframe	Day 10
End point values Selenase Placebo Number of subjects analysed 7 [13] 9 [14] Units: mg / dl     arithmetic mean (standard deviation) 0.530 ( 0.416 ) 0.6422 ( 0.8226 )
Notes [13] - 4 missing data [14] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 10 Top of page

Secondary: Bilirubin - Day 11 Top of page
End point title	Bilirubin - Day 11
End point description
End point type	Secondary
End point timeframe	Day 11
End point values Selenase Placebo Number of subjects analysed 7 [15] 9 [16] Units: mg / dl     arithmetic mean (standard deviation) 0.5343 ( 0.4257 ) 0.6011 ( 0.7194 )
Notes [15] - 4 missing data [16] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 11 Top of page

Secondary: Bilirubin - Day 12 Top of page
End point title	Bilirubin - Day 12
End point description
End point type	Secondary
End point timeframe	Day 12
End point values Selenase Placebo Number of subjects analysed 7 [17] 9 [18] Units: mg / dl     arithmetic mean (standard deviation) 0.4871 ( 0.2840 ) 0.5867 ( 0.7055 )
Notes [17] - 4 missing data [18] - 1 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 12 Top of page

Secondary: Bilirubin - Day 13 Top of page
End point title	Bilirubin - Day 13
End point description
End point type	Secondary
End point timeframe	Day 13
End point values Selenase Placebo Number of subjects analysed 7 [19] 8 [20] Units: mg / dl     arithmetic mean (standard deviation) 0.5329 ( 0.2749 ) 0.7175 ( 0.9034 )
Notes [19] - 4 missing data [20] - 2 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 13 Top of page

Secondary: Bilirubin - Day 14 Top of page
End point title	Bilirubin - Day 14
End point description
End point type	Secondary
End point timeframe	Day 14
End point values Selenase Placebo Number of subjects analysed 7 [21] 7 [22] Units: mg / dl     arithmetic mean (standard deviation) 0.6243 ( 0.2995 ) 0.7114 ( 0.9646 )
Notes [21] - 4 missing data [22] - 3 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 14 Top of page

Secondary: Bilirubin - Day 15 Top of page
End point title	Bilirubin - Day 15
End point description
End point type	Secondary
End point timeframe	Day 15
End point values Selenase Placebo Number of subjects analysed 7 [23] 7 [24] Units: mg / dl     arithmetic mean (standard deviation) 1.019 ( 1.016 ) 0.7914 ( 1.0291 )
Notes [23] - 4 missing data [24] - 3 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 15 Top of page

Secondary: Bilirubin - Day 16 Top of page
End point title	Bilirubin - Day 16
End point description
End point type	Secondary
End point timeframe	Day 16
End point values Selenase Placebo Number of subjects analysed 6 [25] 6 [26] Units: mg / dl     arithmetic mean (standard deviation) 1.30 ( 1.3480 ) 0.8217 ( 1.0916 )
Notes [25] - 5 missing data [26] - 4 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 16 Top of page

Secondary: Bilirubin - Day 17 Top of page
End point title	Bilirubin - Day 17
End point description
End point type	Secondary
End point timeframe	Day 17
End point values Selenase Placebo Number of subjects analysed 4 [27] 5 [28] Units: mg / dl     arithmetic mean (standard deviation) 0.5850 ( 0.2625 ) 1.164 ( 1.686 )
Notes [27] - 7 missing data [28] - 5 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 17 Top of page

Secondary: Bilirubin - Day 18 Top of page
End point title	Bilirubin - Day 18
End point description
End point type	Secondary
End point timeframe	Day 18
End point values Selenase Placebo Number of subjects analysed 4 [29] 5 [30] Units: mg / dl     arithmetic mean (standard deviation) 0.4850 ( 0.1841 ) 1.052 ( 1.052 )
Notes [29] - 7 missing data [30] - 5 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 18 Top of page

Secondary: Bilirubin - Day 19 Top of page
End point title	Bilirubin - Day 19
End point description
End point type	Secondary
End point timeframe	Day 19
End point values Selenase Placebo Number of subjects analysed 4 [31] 5 [32] Units: mg / dl     arithmetic mean (standard deviation) 0.4350 ( 0.1237 ) 1.002 ( 1.367 )
Notes [31] - 7 missing data [32] - 5 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 19 Top of page

Secondary: Bilirubin - Day 20 Top of page
End point title	Bilirubin - Day 20
End point description
End point type	Secondary
End point timeframe	Day 20
End point values Selenase Placebo Number of subjects analysed 4 [33] 5 [34] Units: mg / dl     arithmetic mean (standard deviation) 0.420 ( 0.1086 ) 1.304 ( 1.996 )
Notes [33] - 7 missing data [34] - 5 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 20 Top of page

Secondary: Bilirubin - Day 21 Top of page
End point title	Bilirubin - Day 21
End point description
End point type	Secondary
End point timeframe	Day 21
End point values Selenase Placebo Number of subjects analysed 3 [35] 4 [36] Units: mg / dl     arithmetic mean (standard deviation) 0.4233 ( 0.1222 ) 1.337 ( 1.924 )
Notes [35] - 8 missing data [36] - 6 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 21 Top of page

Secondary: Bilirubin - Day 22 Top of page
End point title	Bilirubin - Day 22
End point description
End point type	Secondary
End point timeframe	Day 22
End point values Selenase Placebo Number of subjects analysed 2 [37] 3 [38] Units: mg / dl     arithmetic mean (standard deviation) 0.490 ( 0.09899 ) 1.557 ( 1.838 )
Notes [37] - 9 missing data [38] - 7 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 22 Top of page

Secondary: Bilirubin - Day 23 Top of page
End point title	Bilirubin - Day 23
End point description
End point type	Secondary
End point timeframe	Day 23
End point values Selenase Placebo Number of subjects analysed 2 [39] 2 [40] Units: mg / dl     arithmetic mean (standard deviation) 0.5850 ( 0.2051 ) 2.235 ( 2.227 )
Notes [39] - 9 missing data [40] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 23 Top of page

Secondary: Bilirubin - Day 24 Top of page
End point title	Bilirubin - Day 24
End point description
End point type	Secondary
End point timeframe	Day 24
End point values Selenase Placebo Number of subjects analysed 2 [41] 2 [42] Units: mg / dl     arithmetic mean (standard deviation) 0.5750 ( 0.1344 ) 3.065 ( 3.429 )
Notes [41] - 9 missing data [42] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 24 Top of page

Secondary: Bilirubin - Day 25 Top of page
End point title	Bilirubin - Day 25
End point description
End point type	Secondary
End point timeframe	Day 25
End point values Selenase Placebo Number of subjects analysed 2 [43] 2 [44] Units: mg / dl     arithmetic mean (standard deviation) 0.480 ( 0.2546 ) 2.80 ( 3.224 )
Notes [43] - 9 missing data [44] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 25 Top of page

Secondary: Bilirubin - Day 26 Top of page
End point title	Bilirubin - Day 26
End point description
End point type	Secondary
End point timeframe	Day 26
End point values Selenase Placebo Number of subjects analysed 2 [45] 2 [46] Units: mg / dl     arithmetic mean (standard deviation) 0.530 ( 0.2687 ) 2.755 ( 3.062 )
Notes [45] - 9 missing data [46] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 26 Top of page

Secondary: Bilirubin - Day 27 Top of page
End point title	Bilirubin - Day 27
End point description
End point type	Secondary
End point timeframe	Day 27
End point values Selenase Placebo Number of subjects analysed 2 [47] 2 [48] Units: mg / dl     arithmetic mean (standard deviation) 0.450 ( 0.01414 ) 3.515 ( 4.137 )
Notes [47] - 9 missing data [48] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 27 Top of page

Secondary: Bilirubin - Day 28 Top of page
End point title	Bilirubin - Day 28
End point description
End point type	Secondary
End point timeframe	Day 28
End point values Selenase Placebo Number of subjects analysed 2 [49] 2 [50] Units: mg / dl     arithmetic mean (standard deviation) 0.390 ( 0.02828 ) 3.840 ( 4.624 )
Notes [49] - 9 missing data [50] - 8 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 28 Top of page

Secondary: Bilirubin - Day 29 Top of page
End point title	Bilirubin - Day 29
End point description
End point type	Secondary
End point timeframe	Day 29
End point values Selenase Placebo Number of subjects analysed 2 [51] 1 [52] Units: mg / dl     arithmetic mean (standard deviation) 0.360 ( 0.02828 ) 0.64 ( 0 )
Notes [51] - 9 missing data [52] - 9 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 29 Top of page

Secondary: Bilirubin - Day 30 Top of page
End point title	Bilirubin - Day 30
End point description
End point type	Secondary
End point timeframe	Day 30
End point values Selenase Placebo Number of subjects analysed 1 [53] 0 [54] Units: mg / dl     arithmetic mean (standard deviation) 0.32 ( 0 ) ( )
Notes [53] - 10 missing data [54] - 10 missing data
No statistical analyses for this end point

Secondary: Bilirubin - Day 30 Top of page

Secondary: Creatinine - Day 1 Top of page
End point title	Creatinine - Day 1
End point description
End point type	Secondary
End point timeframe	Day 1
End point values Selenase Placebo Number of subjects analysed 11 10 Units: mg / dl     arithmetic mean (standard deviation) 1.6482 ( 0.6442 ) 1.3250 ( 0.3832 )
No statistical analyses for this end point

Secondary: Creatinine - Day 1 Top of page

Secondary: Creatinine - Day 2 Top of page
End point title	Creatinine - Day 2
End point description
End point type	Secondary
End point timeframe	Day 2
End point values Selenase Placebo Number of subjects analysed 9 [55] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.6989 ( 0.9114 ) 1.2560 ( 0.3838 )
Notes [55] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 2 Top of page

Secondary: Creatinine - Day 3 Top of page
End point title	Creatinine - Day 3
End point description
End point type	Secondary
End point timeframe	Day 3
End point values Selenase Placebo Number of subjects analysed 9 [56] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.6833 ( 0.9721 ) 1.2040 ( 0.3923 )
Notes [56] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 3 Top of page

Secondary: Creatinine - Day 4 Top of page
End point title	Creatinine - Day 4
End point description
End point type	Secondary
End point timeframe	Day 4
End point values Selenase Placebo Number of subjects analysed 9 [57] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.4578 ( 0.7929 ) 1.1560 ( 0.3631 )
Notes [57] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 4 Top of page

Secondary: Creatinine - Day 5 Top of page
End point title	Creatinine - Day 5
End point description
End point type	Secondary
End point timeframe	Day 5
End point values Selenase Placebo Number of subjects analysed 9 [58] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.3233 ( 0.5042 ) 1.1690 ( 0.4626 )
Notes [58] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 5 Top of page

Secondary: Creatinine - Day 6 Top of page
End point title	Creatinine - Day 6
End point description
End point type	Secondary
End point timeframe	Day 6
End point values Selenase Placebo Number of subjects analysed 9 [59] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.2256 ( 0.4189 ) 1.0870 ( 0.4529 )
Notes [59] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 6 Top of page

Secondary: Creatinine - Day 7 Top of page
End point title	Creatinine - Day 7
End point description
End point type	Secondary
End point timeframe	Day 7
End point values Selenase Placebo Number of subjects analysed 9 [60] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.1422 ( 0.3986 ) 0.9718 ( 0.4830 )
Notes [60] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 7 Top of page

Secondary: Creatinine - Day 8 Top of page
End point title	Creatinine - Day 8
End point description
End point type	Secondary
End point timeframe	Day 8
End point values Selenase Placebo Number of subjects analysed 9 [61] 9 [62] Units: mg / dl     arithmetic mean (standard deviation) 1.154 ( 0.419 ) 1.0144 ( 0.3776 )
Notes [61] - 2 missing data [62] - 1 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 8 Top of page

Secondary: Creatinine - Day 9 Top of page
End point title	Creatinine - Day 9
End point description
End point type	Secondary
End point timeframe	Day 9
End point values Selenase Placebo Number of subjects analysed 7 [63] 9 [64] Units: mg / dl     arithmetic mean (standard deviation) 1.3357 ( 0.4266 ) 1.0122 ( 0.3502 )
Notes [63] - 4 missing data [64] - 1 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 9 Top of page

Secondary: Creatinine - Day 10 Top of page
End point title	Creatinine - Day 10
End point description
End point type	Secondary
End point timeframe	Day 10
End point values Selenase Placebo Number of subjects analysed 7 [65] 9 [66] Units: mg / dl     arithmetic mean (standard deviation) 1.3414 ( 0.5286 ) 1.0056 ( 0.3371 )
Notes [65] - 4 missing data [66] - 1 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 10 Top of page

Secondary: Creatinine - Day 11 Top of page
End point title	Creatinine - Day 11
End point description
End point type	Secondary
End point timeframe	Day 11
End point values Selenase Placebo Number of subjects analysed 8 [67] 10 Units: mg / dl     arithmetic mean (standard deviation) 1.3050 ( 0.4248 ) 1.0350 ( 0.3655 )
Notes [67] - 3 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 11 Top of page

Secondary: Creatinine - Day 12 Top of page
End point title	Creatinine - Day 12
End point description
End point type	Secondary
End point timeframe	Day 12
End point values Selenase Placebo Number of subjects analysed 7 [68] 9 [69] Units: mg / dl     arithmetic mean (standard deviation) 1.430 ( 0.6019 ) 1.0144 ( 0.3259 )
Notes [68] - 4 missing data [69] - 1 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 12 Top of page

Secondary: Creatinine - Day 13 Top of page
End point title	Creatinine - Day 13
End point description
End point type	Secondary
End point timeframe	Day 13
End point values Selenase Placebo Number of subjects analysed 7 [70] 8 [71] Units: mg / dl     arithmetic mean (standard deviation) 1.4429 ( 0.7067 ) 0.9062 ( 0.2370 )
Notes [70] - 4 missing data [71] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 13 Top of page

Secondary: Creatinine - Day 14 Top of page
End point title	Creatinine - Day 14
End point description
End point type	Secondary
End point timeframe	Day 14
End point values Selenase Placebo Number of subjects analysed 7 [72] 8 [73] Units: mg / dl     arithmetic mean (standard deviation) 1.4486 ( 0.6592 ) 1.0962 ( 0.2752 )
Notes [72] - 4 missing data [73] - 2 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 14 Top of page

Secondary: Creatinine - Day 15 Top of page
End point title	Creatinine - Day 15
End point description
End point type	Secondary
End point timeframe	Day 15
End point values Selenase Placebo Number of subjects analysed 7 [74] 7 [75] Units: mg / dl     arithmetic mean (standard deviation) 1.4114 ( 0.8095 ) 1.1586 ( 0.3938 )
Notes [74] - 4 missing data [75] - 3 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 15 Top of page

Secondary: Creatinine - Day 16 Top of page
End point title	Creatinine - Day 16
End point description
End point type	Secondary
End point timeframe	Day 16
End point values Selenase Placebo Number of subjects analysed 6 [76] 7 [77] Units: mg / dl     arithmetic mean (standard deviation) 1.5083 ( 0.6632 ) 1.1771 ( 0.4342 )
Notes [76] - 5 missing data [77] - 3 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 16 Top of page

Secondary: Creatinine - Day 17 Top of page
End point title	Creatinine - Day 17
End point description
End point type	Secondary
End point timeframe	Day 17
End point values Selenase Placebo Number of subjects analysed 4 [78] 5 [79] Units: mg / dl     arithmetic mean (standard deviation) 1.3450 ( 0.3423 ) 1.3940 ( 0.6742 )
Notes [78] - 7 missing data [79] - 5 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 17 Top of page

Secondary: Creatinine - Day 18 Top of page
End point title	Creatinine - Day 18
End point description
End point type	Secondary
End point timeframe	Day 18
End point values Selenase Placebo Number of subjects analysed 4 [80] 5 [81] Units: mg / dl     arithmetic mean (standard deviation) 1.220 ( 0.3753 ) 1.3460 ( 0.7241 )
Notes [80] - 7 missing data [81] - 5 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 18 Top of page

Secondary: Creatinine - Day 19 Top of page
End point title	Creatinine - Day 19
End point description
End point type	Secondary
End point timeframe	Day 19
End point values Selenase Placebo Number of subjects analysed 4 [82] 5 [83] Units: mg / dl     arithmetic mean (standard deviation) 1.0575 ( 0.260 ) 1.2820 ( 0.5681 )
Notes [82] - 7 missing data [83] - 5 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 19 Top of page

Secondary: Creatinine - Day 20 Top of page
End point title	Creatinine - Day 20
End point description
End point type	Secondary
End point timeframe	Day 20
End point values Selenase Placebo Number of subjects analysed 4 [84] 5 [85] Units: mg / dl     arithmetic mean (standard deviation) 1.080 ( 0.3383 ) 1.3580 ( 0.6242 )
Notes [84] - 7 missing data [85] - 5 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 20 Top of page

Secondary: Creatinine - Day 21 Top of page
End point title	Creatinine - Day 21
End point description
End point type	Secondary
End point timeframe	Day 21
End point values Selenase Placebo Number of subjects analysed 3 [86] 4 [87] Units: mg / dl     arithmetic mean (standard deviation) 0.940 ( 0.2646 ) 1.425 ( 0.622 )
Notes [86] - 8 missing data [87] - 6 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 21 Top of page

Secondary: Creatinine - Day 22 Top of page
End point title	Creatinine - Day 22
End point description
End point type	Secondary
End point timeframe	Day 22
End point values Selenase Placebo Number of subjects analysed 2 [88] 3 [89] Units: mg / dl     arithmetic mean (standard deviation) 1.070 ( 0.3818 ) 1.420 ( 0.3904 )
Notes [88] - 9 missing data [89] - 7 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 22 Top of page

Secondary: Creatinine - Day 23 Top of page
End point title	Creatinine - Day 23
End point description
End point type	Secondary
End point timeframe	Day 23
End point values Selenase Placebo Number of subjects analysed 2 [90] 2 [91] Units: mg / dl     arithmetic mean (standard deviation) 1.170 ( 0.3111 ) 1.330 ( 0.2546 )
Notes [90] - 9 missing data [91] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 23 Top of page

Secondary: Creatinine - Day 24 Top of page
End point title	Creatinine - Day 24
End point description
End point type	Secondary
End point timeframe	Day 24
End point values Selenase Placebo Number of subjects analysed 2 [92] 2 [93] Units: mg / dl     arithmetic mean (standard deviation) 1.090 ( 0.1273 ) 1.20 ( 0.01414 )
Notes [92] - 9 missing data [93] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 24 Top of page

Secondary: Creatinine - Day 25 Top of page
End point title	Creatinine - Day 25
End point description
End point type	Secondary
End point timeframe	Day 25
End point values Selenase Placebo Number of subjects analysed 2 [94] 2 [95] Units: mg / dl     arithmetic mean (standard deviation) 0.870 ( 0.1838 ) 1.0450 ( 0.1344 )
Notes [94] - 9 missing data [95] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 25 Top of page

Secondary: Creatinine - Day 26 Top of page
End point title	Creatinine - Day 26
End point description
End point type	Secondary
End point timeframe	Day 26
End point values Selenase Placebo Number of subjects analysed 2 [96] 2 [97] Units: mg / dl     arithmetic mean (standard deviation) 0.8450 ( 0.2616 ) 1.0350 ( 0.1909 )
Notes [96] - 9 missing data [97] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 26 Top of page

Secondary: Creatinine - Day 27 Top of page
End point title	Creatinine - Day 27
End point description
End point type	Secondary
End point timeframe	Day 27
End point values Selenase Placebo Number of subjects analysed 2 [98] 2 [99] Units: mg / dl     arithmetic mean (standard deviation) 0.810 ( 0.4525 ) 0.960 ( 0.09899 )
Notes [98] - 9 missing data [99] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 27 Top of page

Secondary: Creatinine - Day 28 Top of page
End point title	Creatinine - Day 28
End point description
End point type	Secondary
End point timeframe	Day 28
End point values Selenase Placebo Number of subjects analysed 2 [100] 2 [101] Units: mg / dl     arithmetic mean (standard deviation) 0.7750 ( 0.3041 ) 0.910 ( 0.07071 )
Notes [100] - 9 missing data [101] - 8 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 28 Top of page

Secondary: Creatinine - Day 29 Top of page
End point title	Creatinine - Day 29
End point description
End point type	Secondary
End point timeframe	Day 29
End point values Selenase Placebo Number of subjects analysed 2 [102] 1 [103] Units: mg / dl     arithmetic mean (standard deviation) 0.730 ( 0.2828 ) 0.96 ( 0 )
Notes [102] - 9 missing data [103] - 9 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 29 Top of page

Secondary: Creatinine - Day 30 Top of page
End point title	Creatinine - Day 30
End point description
End point type	Secondary
End point timeframe	Day 30
End point values Selenase Placebo Number of subjects analysed 2 [104] 1 [105] Units: mg / dl     arithmetic mean (standard deviation) 0.630 ( 0.08485 ) 0.92 ( 0 )
Notes [104] - 9 missing data [105] - 9 missing data
No statistical analyses for this end point

Secondary: Creatinine - Day 30 Top of page

Secondary: IL-6 - Baseline Top of page
End point title	IL-6 - Baseline
End point description
End point type	Secondary
End point timeframe	Baseline
End point values Selenase Placebo Number of subjects analysed 10 [106] 10 Units: pg / ml     arithmetic mean (standard deviation) 31.910 ( 82.533 ) 7.288 ( 10.605 )
Notes [106] - 1 missing data
No statistical analyses for this end point

Secondary: IL-6 - Baseline Top of page

Secondary: IL-6 - Day 0 Top of page
End point title	IL-6 - Day 0
End point description
End point type	Secondary
End point timeframe	Day 0
End point values Selenase Placebo Number of subjects analysed 9 [107] 10 Units: pg / ml     arithmetic mean (standard deviation) 365.526 ( 396.512 ) 248.678 ( 212.787 )
Notes [107] - 2 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 0 Top of page

Secondary: IL-6 - Day 1 Top of page
End point title	IL-6 - Day 1
End point description
End point type	Secondary
End point timeframe	Day 1
End point values Selenase Placebo Number of subjects analysed 9 [108] 10 Units: pg / ml     arithmetic mean (standard deviation) 156.035 ( 91.049 ) 191.948 ( 139.490 )
Notes [108] - 2 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 1 Top of page

Secondary: IL-6 - Day 3 Top of page
End point title	IL-6 - Day 3
End point description
End point type	Secondary
End point timeframe	Day 3
End point values Selenase Placebo Number of subjects analysed 9 [109] 10 Units: pg / ml     arithmetic mean (standard deviation) 115.276 ( 84.364 ) 148.111 ( 165.305 )
Notes [109] - 2 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 3 Top of page

Secondary: IL-6 - Day 5 Top of page
End point title	IL-6 - Day 5
End point description
End point type	Secondary
End point timeframe	Day 5
End point values Selenase Placebo Number of subjects analysed 9 [110] 9 [111] Units: pg / ml     arithmetic mean (standard deviation) 68.465 ( 67.037 ) 56.891 ( 34.977 )
Notes [110] - 2 missing data [111] - 1 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 5 Top of page

Secondary: IL-6 - Day 7 Top of page
End point title	IL-6 - Day 7
End point description
End point type	Secondary
End point timeframe	Day 7
End point values Selenase Placebo Number of subjects analysed 9 [112] 9 [113] Units: pg / ml     arithmetic mean (standard deviation) 50.986 ( 34.452 ) 88.696 ( 44.160 )
Notes [112] - 2 missing data [113] - 1 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 7 Top of page

Secondary: IL-6 - Day 13 Top of page
End point title	IL-6 - Day 13
End point description
End point type	Secondary
End point timeframe	Day 13
End point values Selenase Placebo Number of subjects analysed 6 [114] 9 [115] Units: pg / ml     arithmetic mean (standard deviation) 71.276 ( 104.124 ) 153.193 ( 257.173 )
Notes [114] - 5 missing data [115] - 1 missing data
No statistical analyses for this end point

Secondary: IL-6 - Day 13 Top of page

Secondary: Selenium - Baseline Top of page
End point title	Selenium - Baseline
End point description
End point type	Secondary
End point timeframe	Baseline
End point values Selenase Placebo Number of subjects analysed 10 [116] 10 Units: µg / l     arithmetic mean (standard deviation) 64.007 ( 16.523 ) 63.509 ( 11.875 )
Notes [116] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Baseline Top of page

Secondary: Selenium - Day 0 Top of page
End point title	Selenium - Day 0
End point description
End point type	Secondary
End point timeframe	Day 0
End point values Selenase Placebo Number of subjects analysed 10 [117] 10 Units: µg / l     arithmetic mean (standard deviation) 144.553 ( 42.835 ) 49.010 ( 9.833 )
Notes [117] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 0 Top of page

Secondary: Selenium - Day 1 Top of page
End point title	Selenium - Day 1
End point description
End point type	Secondary
End point timeframe	Day 1
End point values Selenase Placebo Number of subjects analysed 10 [118] 10 Units: µg / l     arithmetic mean (standard deviation) 102.397 ( 22.718 ) 44.913 ( 7.981 )
Notes [118] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 1 Top of page

Secondary: Selenium - Day 3 Top of page
End point title	Selenium - Day 3
End point description
End point type	Secondary
End point timeframe	Day 3
End point values Selenase Placebo Number of subjects analysed 9 [119] 10 Units: µg / l     arithmetic mean (standard deviation) 100.406 ( 24.496 ) 43.607 ( 11.135 )
Notes [119] - 2 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 3 Top of page

Secondary: Selenium - Day 5 Top of page
End point title	Selenium - Day 5
End point description
End point type	Secondary
End point timeframe	Day 5
End point values Selenase Placebo Number of subjects analysed 9 [120] 9 [121] Units: µg / l     arithmetic mean (standard deviation) 114.742 ( 20.977 ) 48.484 ( 13.328 )
Notes [120] - 2 missing data [121] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 5 Top of page

Secondary: Selenium - Day 7 Top of page
End point title	Selenium - Day 7
End point description
End point type	Secondary
End point timeframe	Day 7
End point values Selenase Placebo Number of subjects analysed 9 [122] 9 [123] Units: µg / l     arithmetic mean (standard deviation) 118.248 ( 17.170 ) 44.433 ( 7.982 )
Notes [122] - 2 missing data [123] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 7 Top of page

Secondary: Selenium - Day 13 Top of page
End point title	Selenium - Day 13
End point description
End point type	Secondary
End point timeframe	Day 13
End point values Selenase Placebo Number of subjects analysed 5 [124] 9 [125] Units: µg / l     arithmetic mean (standard deviation) 130.978 ( 26.623 ) 47.977 ( 11.133 )
Notes [124] - 6 missing data [125] - 1 missing data
No statistical analyses for this end point

Secondary: Selenium - Day 13 Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	14 days (day before surgery till ICU release or POD 13)
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	none
Dictionary version	0
Reporting groups
Reporting group title	Selenase
Reporting group description	-
Reporting group title	Placebo
Reporting group description	-
Serious adverse events Selenase Placebo Total subjects affected by serious adverse events      subjects affected / exposed 7 / 11 (63.64%) 3 / 10 (30.00%)      number of deaths (all causes) 2 2      number of deaths resulting from adverse events 0 0 Cardiac disorders Cardiac decompensation      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Medial infarct      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pericardial effusion      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Arrhythmia      subjects affected / exposed 2 / 11 (18.18%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Pericardial tamponade      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Acute cardiopulmonary decompensation      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Circulatory failure      subjects affected / exposed 0 / 11 (0.00%) 2 / 10 (20.00%)      occurrences causally related to treatment / all 0 / 0 0 / 2      deaths causally related to treatment / all 0 / 0 0 / 2 Hypertensive crisis      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Nervous system disorders Hemiparesis      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Delirium      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences causally related to treatment / all 0 / 1 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Gastrointestinal disorders Diarrhoea      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Re-intubation      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 1 0 / 0 Pleural effusion      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 Pneumothorax      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Renal and urinary disorders Renal failure      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 Infections and infestations Driveline infection      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Selenase Placebo Total subjects affected by non serious adverse events      subjects affected / exposed 8 / 11 (72.73%) 6 / 10 (60.00%) Vascular disorders Hemorrhage      subjects affected / exposed 3 / 11 (27.27%) 1 / 10 (10.00%)      occurrences all number 4 1 Epistaxis      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences all number 1 1 Cardiac disorders Ventricular tachycardia      subjects affected / exposed 1 / 11 (9.09%) 2 / 10 (20.00%)      occurrences all number 1 3 Tachyarrhythmia absoluta      subjects affected / exposed 3 / 11 (27.27%) 3 / 10 (30.00%)      occurrences all number 3 3 Cardiac arrhythmia      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Right heart failure      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences all number 1 1 Pericardial effusion      subjects affected / exposed 2 / 11 (18.18%) 1 / 10 (10.00%)      occurrences all number 2 1 Nervous system disorders Delirium      subjects affected / exposed 2 / 11 (18.18%) 2 / 10 (20.00%)      occurrences all number 2 2 Seizure      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Blood and lymphatic system disorders Leukocytosis      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 1 Thrombocytopenia type II      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 1 Eye disorders Flickering before the eye      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Gastrointestinal disorders Paralytic ileus      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 1 Gastritis      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 1 Tarry stool      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Hepatobiliary disorders Hepatic failure      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences all number 1 1 Respiratory, thoracic and mediastinal disorders Pleural effusion      subjects affected / exposed 3 / 11 (27.27%) 2 / 10 (20.00%)      occurrences all number 3 2 Prolonged weaning      subjects affected / exposed 2 / 11 (18.18%) 1 / 10 (10.00%)      occurrences all number 2 1 Respiratory insufficiency      subjects affected / exposed 2 / 11 (18.18%) 1 / 10 (10.00%)      occurrences all number 2 1 Skin and subcutaneous tissue disorders Sternal wound healing disorder      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Renal and urinary disorders Renal failure      subjects affected / exposed 3 / 11 (27.27%) 1 / 10 (10.00%)      occurrences all number 3 1 Urosepsis      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 2 0 Renal insufficiency      subjects affected / exposed 1 / 11 (9.09%) 0 / 10 (0.00%)      occurrences all number 1 0 Musculoskeletal and connective tissue disorders Critical illness myopathy / Critical illness polyneuropathy      subjects affected / exposed 2 / 11 (18.18%) 0 / 10 (0.00%)      occurrences all number 2 0 Infections and infestations Pneumonia      subjects affected / exposed 3 / 11 (27.27%) 3 / 10 (30.00%)      occurrences all number 4 3 Sepsis      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences all number 1 1 Septic shock      subjects affected / exposed 2 / 11 (18.18%) 1 / 10 (10.00%)      occurrences all number 2 1 Driveline infection      subjects affected / exposed 1 / 11 (9.09%) 1 / 10 (10.00%)      occurrences all number 1 1 Infection      subjects affected / exposed 0 / 11 (0.00%) 1 / 10 (10.00%)      occurrences all number 0 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

More information Top of page