Thiamine as an Adjunctive Therapy in Cardiac Surgery

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: American Heart Association; University of Aarhus
• Treatments: Pharmaceutical Solutions; Thiamine; Vitamin B Complex; Vitamins

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)