Thiamine Supplementation in High Risk Cardiac Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This pilot trial will evaluate the ability of thiamine to affect on postoperative vasoplegia in high risk cardiac surgery patients
详细描述
Thiamine has a pivotal role and is an essential cofactor for pyruvate dehydrogenase activity. Widely known wet beri-beri is developed due to thiamine deficiency and characterized by vasodilatory shock and despaired oxygen extraction leading to kidney, heart and central nervous system dysfunction. Thiamine deficiency is often underestimated and even in primary absence of vitamin B1 deficiency, high-consumptive state of many critical illness and cardiac surgery itself can lead to its lack. Reported that in patients on chronic dialysis and patients with AKI requiring RRT thiamine deficiency is a usual finding. In cross-sectional observational study it has been shown that up to 33% of patients with a diagnosis of congestive heart failure (CHF) had thiamine deficiency due to chronic loop diuretic use. Also reported that 96% of patients (21 of 23) with heart failure receiving loop diuretic therapy (daily dose: 80-240 mg furosemide) developed thiamine deficiency. In prospective observational trial it has been shown that plasma thiamine levels were decreased after CABG surgery.
In a secondary analysis of a randomized, double-blind, placebo-controlled trial conducted in septic patients, thiamine supplementation showed highly-promising renal protective effect. Need for RRT was 8 patients (21%) in placebo group and 1 patient (3%) in thiamine group (p=0.04).
On the other hand it was unable to show any benefit of thiamine supplementation in patients undergoing CABG surgery. Although, postoperative oxygen consumption was significantly increased among patients receiving thiamine.
Nevertheless, existing evidence suggests that thiamine supplementation might be an attractive strategy in counteracting organ dysfunction and thus morbidity and mortality in high-risk cardiac surgical patients.
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, Care Provider, Investigator)
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
- •Valve surgery + CABG that required cardiac surgery with CPB
- •Aged 18 years or older
- •Signed informed consent
排除标准
- •Emergency surgery
- •Chronic kidney disease of G4-G5 categories according to KDIGO criteria (at least one of the following present for > 3 months: glomerular filtration rate ≤ 29 ml/min/1.73 m2, history of kidney transplantation)
- •Known allergy to thiamine
- •Pregnancy
- •Current enrollment into another RCT (in the last 30 days)
- •Previous enrollment and randomisation into the APPLY trial
- •Administration of thiamine in the previous 30 day
研究组 & 干预措施
Thiamine group
干预措施: Thiamine hydrochloride (200mg) dissolved in 100 ml of normal saline (Drug)
Placebo group
干预措施: Normal saline (100ml) (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 8 month
Recruitment of trial patients: successful recruitment is defined as 2 patients per week on average
Compliance with the protocol
时间窗: 8 month
Successful compliance with protocol is defined as ≥ 90% of prescribed intervention being administered across all patients
次要结局
- The daily incidence of cardiovascular and renal dysfunction according to Sequential Organ Failure Assessment (SOFA) score during 48 hours postoperatively(48 hours)
- Incidence of Treatment-Emergent Adverse Events(30 days)
- Peak lactate level after CPB weaning to 48 hours(48 hours)
- Rates of postoperative complications(30 days)
- Vasoinotropic score(3 days)
- The value of postoperative peak serum creatinine concentration during 3 postoperative days(3 days)
- The incidence of acute kidney injury (AKI) according to "Kidney Disease: Improving Global Outcomes (KDIGO) criteria" during ICU stay(30 days)
- 7-day all-cause mortality (or mortality at any time during the first hospitalization)(7 days)
- Availability of data needed(8 month)
- 30-day all-cause mortality(30 days)
研究者
Efremov Sergey
MD PHD Principal Investigator
Meshalkin Research Institute of Pathology of Circulation