Clinical Trial Results:
High dose steroids in liver resection – effects on complications and endothelial function in the immediate postoperative phase. A randomized, double-blind, controlled trial
|
Summary
|
|
EudraCT number |
2017-002652-81 |
Trial protocol |
DK |
Global end of trial date |
28 Sep 2020
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
21 May 2022
|
First version publication date |
21 May 2022
|
Other versions |
|
Summary report(s) |
article |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
DEXLEV01
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT03403517 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Rigshospitalet
|
||
Sponsor organisation address |
Blegdamsvej 9, 2200, Denmark,
|
||
Public contact |
Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 35451003,
|
||
Scientific contact |
Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 35451003,
|
||
|
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 |
28 Sep 2020
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
28 Aug 2020
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 Sep 2020
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To investigate the effects of high dose steroids on complications after liver resection
|
||
Protection of trial subjects |
all procedures were standard protocol
|
||
Background therapy |
standard procedure, eras described elsewhere | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Sep 2017
|
||
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 |
Denmark: 174
|
||
Worldwide total number of subjects |
174
|
||
EEA total number of subjects |
174
|
||
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) |
50
|
||
From 65 to 84 years |
94
|
||
85 years and over |
30
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
- | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
All patients scheduled for open liver surgery without biliary reconstruction were consecutively screened for inclusion. Patients considered were 18 years of age or older, and able to provide informed oral and written consent. Exclusion criteria were: planned simultaneous operation on other organs, simultaneous operation for hernia with inserti | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
overall trial (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Double blind | |||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Carer, Assessor, Subject | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
high dose glucocorticoid | |||||||||
Arm description |
10 mg/kg methylprednisolone | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
methylprednisolone
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
|
|||||||||
Routes of administration |
Intravenous drip use
|
|||||||||
Dosage and administration details |
The high-dose (HD) group received 10 mg/kg methylprednisolone
(Solu-medrolVR , Pfizer, Ballerup, Denmark)
|
|||||||||
|
Arm title
|
standard dose glucocorticoid | |||||||||
Arm description |
8 mg dexamethasone | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
dexamethasone
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Concentrate and solvent for concentrate for solution for infusion
|
|||||||||
Routes of administration |
Intravenous drip use
|
|||||||||
Dosage and administration details |
the standard-dose
(SD) group received 8mg dexamethasone (Dexavit; Vital Pharma
Nordic, Denmark).
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
high dose glucocorticoid
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
10 mg/kg methylprednisolone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
standard dose glucocorticoid
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
8 mg dexamethasone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
high dose glucocorticoid
|
||
Reporting group description |
10 mg/kg methylprednisolone | ||
Reporting group title |
standard dose glucocorticoid
|
||
Reporting group description |
8 mg dexamethasone | ||
|
||||||||||
End point title |
primary eindpoint | |||||||||
End point description |
Number of patients with a complication in the post anesthesia care unit
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
the duration of the trial
|
|||||||||
|
||||||||||
Statistical analysis title |
rr | |||||||||
Statistical analysis description |
risk ratio
|
|||||||||
Comparison groups |
high dose glucocorticoid v standard dose glucocorticoid
|
|||||||||
Number of subjects included in analysis |
174
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
= 0.213 | |||||||||
Method |
Chi-squared | |||||||||
Parameter type |
Risk ratio (RR) | |||||||||
Point estimate |
0.86
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
0.68 | |||||||||
upper limit |
1.08 | |||||||||
Variability estimate |
Standard deviation
|
|||||||||
|
|||
|
Adverse events information [1]
|
|||
Timeframe for reporting adverse events |
trial period + 30 days
|
||
Assessment type |
Systematic | ||
|
Dictionary used for adverse event reporting
|
|||
Dictionary name |
icd-10 | ||
Dictionary version |
10
|
||
| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: see the publication |
|||
|
|||
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 | |||
Online references |
|||
| http://www.ncbi.nlm.nih.gov/pubmed/34480563 |
|||
