The Thiamine Administration After Cardiac Surgery Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Lactate
研究概览
简要总结
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
We hypothesize that thiamine supplementation improves the clearance of lactate in the first 24 hours after cardiac surgery with extracorporeal circulation in patients with high lactate concentration.
详细描述
Thiamine (Vitamin B1) is essential for cell function and as a co-factor of the enzyme Pyruvate Dehydrogenase to initiate the Krebs cycle and thus the aerobic metabolism of glucose.
Thiamine deficiency, can be caused by alcoholism or bariatric surgery and is associated with severe complications such as Wernicke's encephalopathy or Beri-Beri syndrome.
Thiamine deficiency can also be the cause for an increase in lactate levels due to the transformation of pyruvate to lactate. An increase in lactate levels is associated with a worse prognostic. A decrease is, on the contrary, associated with an improved prognostic, during CPR and also after cardiac arrest.
Recently, studies have shown that thiamine deficiency is underdiagnosed in ICU patients.
On top of this, extra-corporeal circulation can worsen this deficiency. This could explain why certain on-pump cardiac surgery patients have increased lactate levels post-operatively, despite optimal blood pressure, cardiac output, diuresis, peripheral perfusion Donnino et al have shown that in a sepsis context thiamine administration improved lactate clearance during the first 24 hours of ICU admission and improved mortality rates at 28 days post-ICU admission.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective cardiac surgery with extra-corporeal circulation in the CHU de Charleroi between November 2020 and December
- •Written informed consent will be obtained from each patient/ family member participating in the study.
排除标准
- •Patients already supplemented with vitamins
- •Patients with an allergy to thiamine
- •Patients who are priorly treated with linezolide, antiretrovirals and/or metformin treatment within 48 hours preoperatively
- •Patients with mitochondrial disorders
- •Patients with Child Pugh C cirrhosis
- •Patients with a history of epilepsy with tonic-clonic movements postoperatively.
- •Pregnant patients
研究组 & 干预措施
Thiamine
Patients in this arm will receive a solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9%.
干预措施: Thiamine 500 MG (Drug)
Placebo
Patients in this arm will receive a solution of 100 ml of NaCl 0.9% alone.
干预措施: Placebo (Drug)
结局指标
主要结局
Lactate
时间窗: 24 hours
Lactate level will be specifically be measured 24h post-ICU admission to evaluate the effect of thiamine versus placebo.
次要结局
- Fluid balance(48 hours)
- Inotropes(48 hours)
- Mechanical ventilation(48 hours)
- Length of ICU stay(5 days)
- Length of hospital stay(30 days)
研究者
Sarah Saxena
MD
Université Libre de Bruxelles