Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acidosis, Lactic; Thiamine Deficiency
• Intervention / Treatment: Drug: Vitamin B1-ratiopharm; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplementation; 6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative	Drug: Vitamin B1-ratiopharm; 300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative; Other Names: Vitamin B1-ratiopharm®
Placebo Comparator: Placebo; 100 ml normal saline, intravenous, preoperative	Drug: Placebo; 100 ml normal saline, intravenous, preoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	2-3 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Michael Hiesmayr, Prof.,MD, MU Vienna

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 2, 2015

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin B1; Cardiac surgery; Thiamine; Lactic Acid; Thiamine Deficiency; Thiamine supplementation
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Acid-Base Imbalance; Acidosis; Acidosis, Lactic; Thiamine Deficiency; Beriberi; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Thiamine
• Other Study ID Numbers: 2011-004080-70 (EudraCT Number)

Drug and device information, study documents

• 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