Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524315
• Other study ID #: 2011-004080-70
• Secondary ID: 2011-004080-70
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2012
• Est. completion date: February 2, 2015

Study information

• Verified date: February 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2, 2015
• Est. primary completion date: February 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Acidosis, Lactic
• Beriberi
• Heart Failure
• Thiamine Deficiency

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Luger M, Hiesmayr M, Köppel P, Sima B, Ranz I, Weiss C, König 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 controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thiamine status and lactate levels	Thiamine status: functional parameter - erythrocyte transketolase (a-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	Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay	Thiamine status: functional parameter - erythrocyte transketolase (a-ETK) expressed as TPP (thiamine pyrophosphate); Body composition: measuring with bioelectrical impedance analysis (BIA) Length of ICU and hospital stay;	2-3 weeks