Thiamine as an Adjunctive Therapy in Cardiac Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Lactate Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 21 years)
- •Coronary artery bypass grafting (CABG) with or without concomitant valve procedures
- •EuroSCORE II > 1.5%
排除标准
- •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)
研究组 & 干预措施
Control Arm
50 mL normal saline solution
干预措施: Normal saline solution (Drug)
Thiamine
200 mg thiamine in 50 mL normal saline solution
干预措施: Thiamine (Drug)
结局指标
主要结局
Lactate Levels
时间窗: Post-surgery within 1 hour of arrival to the ICU
次要结局
- Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity(Post-surgery within 1 hour of arrival to the ICU)
- Patients With Post-operative Complications(Until hospital discharge, limit 60 days)
- Mortality(Until hospital discharge, limit 60 days)
- Length of Stay(Until hospital discharge, limit 60 days)
研究者
Michael Donnino
M.D.
Beth Israel Deaconess Medical Center