Text Size

Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Hiesmayr, Prof. MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01524315
First received: January 30, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure
Acidosis, Lactic
Thiamine Deficiency
 Drug: Vitamin B1-ratiopharm
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Thiamine status and lactate levels [ Time Frame: perioperative ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Prevalence of thiamine deficiency, identification of body composition and length of hospital and ICU stay [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    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;


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Vitamin B1-ratiopharm®
Placebo Comparator: Placebo
100 ml normal saline, intravenous, preoperative
 Drug: Placebo
100 ml normal saline, intravenous, preoperative

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524315

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Hiesmayr, Prof.,MD MU Vienna
  More Information

No publications provided

Responsible Party: Michael Hiesmayr, Prof. MD, Michael Hiesmayr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01524315     History of Changes
Other Study ID Numbers: 2011-004080-70, 2011-004080-70
Study First Received: January 30, 2012
Last Updated: May 14, 2013
Health Authority: Austria: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Thiamine
Vitamin B1
Thiamine Deficiency
 Thiamine supplementation
Cardiac surgery
Lactic Acid

Additional relevant MeSH terms:
Acidosis
Acidosis, Lactic
Heart Failure
Thiamine Deficiency
Beriberi
Acid-Base Imbalance
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Vitamin B Deficiency
Avitaminosis
 Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013