Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2015-02-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure Acidosis, Lactic Thiamine Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Supplementation

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

Group Type EXPERIMENTAL

Vitamin B1-ratiopharm

Intervention Type DRUG

300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative

Placebo

100 ml normal saline, intravenous, preoperative

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 ml normal saline, intravenous, preoperative

Interventions

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Vitamin B1-ratiopharm

300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative

Intervention Type DRUG

Placebo

100 ml normal saline, intravenous, preoperative

Intervention Type DRUG

Other Intervention Names

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Vitamin B1-ratiopharm®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No