Clinical Trials Register

Summary
EudraCT Number:	2011-004080-70
Sponsor's Protocol Code Number:
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-11-03
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2011-004080-70

A.3

Full title of the trial

Preoperative parenteral thiamine supplementation in patients undergoing heart surgery – a pilot study

Präoperativ parenterale Thiamin Supplementierung bei Patienten/innen mit Herz Operation

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Preoperative parenteral thiamine supplementation in patients undergoing heart surgery

Präoperativ parenterale Thiamin Supplementierung bei Patienten/innen mit Herz Operation

A.4.1

Sponsor's protocol code number

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Med. Univ. Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Med. Univ. Wien
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Med. Univ. Wien
B.5.2	Functional name of contact point	Karin Schindler
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.6	E-mail	karin.schindler@meduniwien.ac.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Vitamin B1-ratiopharm
D.2.1.1.2	Name of the Marketing Authorisation holder	ratiopharm GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Vitamin B1 –ratiopharm
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	67-03-8
D.3.9.3	Other descriptive name	THIAMINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04798MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate and solvent for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The objective of this study is to determine the prevalence of thiamine deficiency (TD) in patients with heart surgery, to examine the association between thiamine levels and lactic acidosis and to prevent the increase of lactate by vitamin B1 supplementation.

Vitamin B1 bzw. Thiamin ist ein wasserlösliches Vitamin und spielt im Energiestoffwechsel eine Rolle. Bis jetzt gibt es keine Studien, welche den Thiamin Status bei Patienten/innen, die eine Herz-Operation erhalten, evaluiert und welche die Prävalenz von Thiamin-Mangel bei dieser Personengruppe feststellt. Aus diesem Grund wird eine Pilotstudie durchgeführt, um das Risiko einer Laktatazidose, aufgrund eines Thiaminmangels, genau bei dieser Patientengruppe zu identifizieren.

E.1.1.1

Medical condition in easily understood language

To determine the prevalence of thiamine deficiency (TD) in patients with heart surgery, to examine the association between thiamine levels and lactic acidosis and to prevent the increase of lactate.

Die Prävalenzbestimmung von Thiamin-Mangel bei Patienten mit Herz OP. Risiko einer Laktatazidose, aufgrund eines Thiaminmangels, genau bei dieser Patientengruppe zu identifizieren.

E.1.1.2

Therapeutic area

Body processes [G] - Physiological processes [G07]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. Primary goals:
o prevalence of vitamin B1 deficiency (thiamine status in erythrocytes, ETK - erythrocyte transketolase)
o intraoperative maximum lactate elevation

E.2.2

Secondary objectives of the trial

o use of vasoactive drugs
o postoperative lactate maximum
o length of hospital stay (from admission to the hospital to discharge from the hospital)
o the length of ICU stay

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

o age 18 – 100 years
o planned heart surgery
o signed informed consent

E.4

Principal exclusion criteria

not specified

E.5 End points

E.5.1

Primary end point(s)

3.2.1 Primary endpoint
• Thiamine status:
o functional parameter: the erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate) effect will be determined photometrically [12, 13]. The primary endpoints are measurements:
at the end of the operation and
24 hours postoperatively
o the quantity of vitamin B1 in urine concentrations will be determined by HPLC methods with fluorescence detection [11-13].
This primary endpoint is the measurement of the urine thiamine concentration by collecting 24-hour-urine after supplementation till ICU stay.
• Lactate levels:
o lactate levels will be determined by blood gas analysis (BGA) within the routine check. The primary endpoints are: the lactate maximum during operation and
area under the curve (AUC) 24 hours postoperatively

E.5.1.1

Timepoint(s) of evaluation of this end point

see above

E.5.2

Secondary end point(s)

• Thiamine status:
o there will be a baseline measurement of erythrocyte transketolase
o measuring the urine thiamine concentration in the first and second day postoperatively by collecting 24-hour-urine
o treatment effect: thiamine status change compared with baseline
• Lactate levels:
o lactate levels will be measured 16 times during surgery, six times in the first 24 hours and one time on the second day postoperatively.
o minimum lactate level postoperatively
• prevalence of thiamine deficiency and association with demographic characteristics (e.g. age, gender, BMI, heart failure, alcohol, drug use (diuretics), malnutrition, weight loss, heart insufficiency, intake of Vitamin B1 by using Food Frequency questionnaire (FFQ), Fragebogen zur Erfassung des Gesundheitsverhaltens (FEG), Subjective Global Assessment (SGA) etc.)
• comparison of lactate levels with thiamine status by quantity (urine) and functional tests (erythrocyte transketolase)
• length of hospital stay (from admission to the hospital to discharge from the hospital)
• the length of ICU stay
• to gather estimates for the difference in outcome parameters in the target population in order to plan a multicenter study

E.5.2.1

Timepoint(s) of evaluation of this end point

not answered

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	100
F.4.2	For a multinational trial
F.4.2.1	In the EEA	100
F.4.2.2	In the whole clinical trial	100

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-06

P. End of Trial
P.	End of Trial Status	Ongoing

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