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Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

Primary Purpose

Heart Failure, Acidosis, Lactic, Thiamine Deficiency

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Vitamin B1-ratiopharm
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Thiamine, Vitamin B1, Thiamine Deficiency, Thiamine supplementation, Cardiac surgery, Lactic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18 - 100 years
  • planned heart surgery
  • signed informed consent

Exclusion Criteria:

  • pregnancy and lactation
  • known allergic reaction to the drugs used
  • mental condition rendering the patient unable to give informed consent
  • inability or contraindications to perform study procedures

Sites / Locations

  • Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplementation

Placebo

Arm Description

6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative

100 ml normal saline, intravenous, preoperative

Outcomes

Primary Outcome Measures

Thiamine status and lactate levels
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); quantity of vitamin B1 in urine and blood concentrations Lactate levels: lactate levels will be determined by blood gas analysis (BGA) within the routine check.

Secondary Outcome Measures

Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); Body composition: measuring with bioelectrical impedance analysis (BIA) Length of ICU and hospital stay;

Full Information

First Posted
January 30, 2012
Last Updated
February 23, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01524315
Brief Title
Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery
Official Title
Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
February 1, 2015 (Actual)
Study Completion Date
February 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine whether preoperative parenteral thiamin supplementation does prevent the intra and early postoperative increase of lactate and whether this effect is related to the extent of thiamine deficiency in patients undergoing heart surgery. In addition the prevalence of major thiamin deficiency in patient undergoing heart surgery will be determined.
Detailed Description
Thiamine (vitamin B1) is a water-soluble vitamin and is involved in several stages of intermediate metabolism which are important for producing energy. Severe thiamin deficiency has been associated with severe lactic acidosis and clinical symptoms of life threatening heart failure. To date, no study has evaluated thiamine levels in patients undergoing heart surgery and the prevalence of thiamine deficiency is not known. Furthermore it is unknown whether moderately reduced thiamin levels are associated with mild forms of perioperative cardiac failure necessitating prolonged inotropic support. In this prospective double blind randomised controlled trial of the effect of a parenteral infusion of thiamin before induction of anaesthesia we will investigate the effect on perioperative lactate increase as primary outcome and extent and duration of inotropic support after cardiac surgery. In addition the pharmacokinetics of a intravenous infusion of 300 mg of thiamin on erythrocyte thiamin content and the amount of thiamine excreted in the 24 hours via the urine will be determined. Baseline thiamin levels in erythrocytes before surgery, as well as nutrition history and body composition will be evaluated as effect modifier.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acidosis, Lactic, Thiamine Deficiency
Keywords
Thiamine, Vitamin B1, Thiamine Deficiency, Thiamine supplementation, Cardiac surgery, Lactic Acid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplementation
Arm Type
Experimental
Arm Description
6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline, intravenous, preoperative
Intervention Type
Drug
Intervention Name(s)
Vitamin B1-ratiopharm
Other Intervention Name(s)
Vitamin B1-ratiopharm®
Intervention Description
300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 ml normal saline, intravenous, preoperative
Primary Outcome Measure Information:
Title
Thiamine status and lactate levels
Description
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); quantity of vitamin B1 in urine and blood concentrations Lactate levels: lactate levels will be determined by blood gas analysis (BGA) within the routine check.
Time Frame
perioperative
Secondary Outcome Measure Information:
Title
Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay
Description
Thiamine status: functional parameter - erythrocyte transketolase (α-ETK) expressed as TPP (thiamine pyrophosphate); Body composition: measuring with bioelectrical impedance analysis (BIA) Length of ICU and hospital stay;
Time Frame
2-3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 - 100 years planned heart surgery signed informed consent Exclusion Criteria: pregnancy and lactation known allergic reaction to the drugs used mental condition rendering the patient unable to give informed consent inability or contraindications to perform study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hiesmayr, Prof.,MD
Organizational Affiliation
MU Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
26066773
Citation
Luger M, Hiesmayr M, Koppel P, Sima B, Ranz I, Weiss C, Konig J, Luger E, Kruschitz R, Ludvik B, Schindler K. Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: A double-blinded, randomised controlled pilot study. Eur J Anaesthesiol. 2015 Aug;32(8):543-8. doi: 10.1097/EJA.0000000000000205.
Results Reference
result

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Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

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