Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

Overview

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.

Full Title of Study: “Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery – a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 1, 2015

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.

Interventions

  • Drug: Vitamin B1-ratiopharm
    • 300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
  • Drug: Placebo
    • 100 ml normal saline, intravenous, preoperative

Arms, Groups and Cohorts

  • Experimental: Supplementation
    • 6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
  • Placebo Comparator: Placebo
    • 100 ml normal saline, intravenous, preoperative

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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;

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael J. Hiesmayr, Michael Hiesmayr – Medical University of Vienna
  • Overall Official(s)
    • Michael Hiesmayr, Prof.,MD, Principal Investigator, MU Vienna

Citations Reporting on Results

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.

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