Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 30, 2012
May 14, 2013
February 2012
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01524315 on ClinicalTrials.gov Archive Site
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;
Same as current
Not Provided
Not Provided
 
Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery
Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Heart Failure
  • Acidosis, Lactic
  • Thiamine Deficiency
  • Drug: Vitamin B1-ratiopharm
    300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
    Other Name: Vitamin B1-ratiopharm®
  • Drug: Placebo
    100 ml normal saline, intravenous, preoperative
  • Experimental: Supplementation
    6 ml Vitamin-B1-ratiopharm in 100 ml normal saline, intravenous, preoperative
    Intervention: Drug: Vitamin B1-ratiopharm
  • Placebo Comparator: Placebo
    100 ml normal saline, intravenous, preoperative
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01524315
2011-004080-70, 2011-004080-70
No
Michael Hiesmayr, Prof. MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Michael Hiesmayr, Prof.,MD MU Vienna
Medical University of Vienna
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP