Thiamine as an Adjunctive Therapy in Cardiac Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | August 2015 |
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.
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.
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.
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.
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)
We found this trial at
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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