Boston, Massachusetts 02215


Purpose:

The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo. The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.


Study summary:

Over 230,000 patients in the United States undergo Coronary Artery Bypass Grafting (CABG) each year. While mortality is relatively low, morbidity remains substantial with a significant risk of prolonged time on mechanical ventilation, prolonged length of hospital and intensive care unit stay and many other complications. CABG causes a profound stress response and significant metabolic alterations occur, including a shift from aerobic to anaerobic metabolism, causing increased levels of pyruvate and lactate. Elevated lactate, a marker of anaerobic metabolism, is a common and significant finding in patients after CABG and is correlated with increased mortality and morbidity. Aerobic metabolism occurs when pyruvate enters the mitochondria through pyruvate decarboxylation to acetyl-Coenzyme A, facilitated by the enzyme pyruvate dehydrogenase (PDH). Decreased PDH activity may cause a shift toward anaerobic metabolism and play a role in the changes seen in patients undergoing CABG. Thiamine (vitamin B1) is a key co-factor for PDH function and will increase activity even in non-deficient states. The investigators hypothesize that thiamine administration will increase PDH activity in patients undergoing CABG, leading to increased cellular oxygen consumption, as represented by decreased lactate levels after surgery, and ultimately improved clinical outcomes. In order to test the investigators' hypothesis and to obtain data for a large-scale clinical trial evaluating relevant clinical endpoints, the investigators are conducting a randomized, double-blind, pilot trial of thiamine in high-risk patients undergoing CABG.


Criteria:

Inclusion Criteria: - Adult (≥ 21 years) - Coronary artery bypass grafting (CABG) with or without concomitant valve procedures - EuroSCORE II > 1.5% Exclusion Criteria: - Current thiamine supplementation - Known allergy to thiamine - Competing indication for thiamine administration as judged by the clinical team (e.g., alcoholic) - Research-protected populations (pregnant women, prisoners, the intellectually disabled) - Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons) - Off-pump surgery (i.e. surgery without cardiopulmonary bypass)


NCT ID:

NCT02322892


Primary Contact:

Principal Investigator
Michael W Donnino, M.D.
Beth Israel Deaconess Medical Center

Michael W Donnino, M.D.
Phone: 671-754-2341
Email: mdonnino@bidmc.harvard.edu


Backup Contact:

Email: lwanders@bidmc.harvard.edu
Lars W Andersen, M.D.
Phone: 671-388-6343


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.