Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery

• ClinicalTrials.gov Identifier: NCT01524315
• Recruitment Status: Unknown
• First Posted: February 1, 2012
• Last Update Posted: May 16, 2013
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Michael Hiesmayr, Prof. MD, Medical University of Vienna

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Acidosis, Lactic; Thiamine Deficiency	Drug: Vitamin B1-ratiopharm; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Preoperative Parenteral Thiamine Supplementation in Patients Undergoing Heart Surgery - a Pilot Study
• Study Start Date: February 2012
• Estimated Primary Completion Date: June 2013
• Estimated Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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;

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 controlled pilot study. Eur J Anaesthesiol. 2015 Aug;32(8):543-8. doi: 10.1097/EJA.0000000000000205.

• Responsible Party: Michael Hiesmayr, Prof. MD, Michael Hiesmayr, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01524315
• Other Study ID Numbers: 2011-004080-70; 2011-004080-70 ( EudraCT Number )
• First Posted: February 1, 2012
• Last Update Posted: May 16, 2013
• Last Verified: May 2013

Keywords provided by Michael Hiesmayr, Prof. MD, Medical University of Vienna:

Thiamine; Vitamin B1; Thiamine Deficiency; Thiamine supplementation; Cardiac surgery; Lactic Acid

Additional relevant MeSH terms:

Acidosis; Thiamine Deficiency; Beriberi; Acidosis, Lactic; Acid-Base Imbalance; Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamins; Thiamine; Vitamin B Complex; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs