Thiamine as an Adjunctive Therapy in Cardiac Surgery

Completed · Phase 2

Conditions studied: Coronary Artery Bypass, Cardiac Surgical Procedures

In brief

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.

Key facts

Study ID

NCT02322892

Run by

Beth Israel Deaconess Medical Center

People needed

64

Starts

2015-01-01

Expected to finish

2015-08-01

Last updated by the study team

2017-03-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (≥ 21 years)
• Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
• EuroSCORE II > 1.5%

You may not qualify if…

• 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)

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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