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NCT Number: NCT01524315

Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

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.

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Key information

Conditions

Heart Failure Acid-Base Imbalance Acidosis Acidosis, Lactic Avitaminosis Cardiovascular Diseases Deficiency Diseases Heart Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Thiamine Deficiency Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B1-ratiopharm

Drug

300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative

Other names: Vitamin B1-ratiopharm®

Placebo

Drug

100 ml normal saline, intravenous, preoperative

Primary outcomes

  1. Thiamine status and lactate levels

    Time frame: perioperative

    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 outcomes

  1. Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay

    Time frame: 2-3 weeks

    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;

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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