The Effect of Remote Ischemic Preconditioning on Mortality and Morbidity in Cardiac Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- In-hospital death
研究概览
简要总结
Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.
详细描述
Perioperative myocardial injury is a serious complication of cardiac surgery. This complication increases both mortality and morbidity of cardiac surgery. Remote ischemic preconditioning (RIPC) is the concept that brief ischemia followed by reperfusion in an organ can reduce subsequent ischemia-reperfusion injury in distant organs. Recent several clinical trials showed powerful myocardial protective effect of remote ischemic preconditioning by reducing postoperative cardiac enzymes. However, the evidence that remote ischemic preconditioning can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a multicenter randomized controlled study to evaluate that remote ischemic preconditioning can improve the outcomes of cardiac surgery.
Purpose:
The purpose of this study is to examine if remote ischemic preconditioning can decrease the mortality and fatal postoperative complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, severe morbidities and duration of hospital stay.
Methods:
Study patients will be randomized to cardiac surgery with RIPC or conventional cardiac surgery in two cardiac surgical centers (Seoul National University Hospital and Asan Medical Center). Remote ischemic preconditioning consists of four 5 min cycles of upper limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg. RIPC is performed twice: before and after the coronary anastomosis in off-pump coronary bypass graft surgery; or before and after the cardiopulmonary bypass in the cardiac valve surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients undergoing cardiac surgery
排除标准
- •emergent operation
- •preoperative use of inotropics or mechanical assist device,
- •left ventricular ejection fraction less than 30%,
- •severe liver, renal and pulmonary disease,
- •recent myocardial infarction (within 7 days),
- •recent systemic infection or sepsis (within 7 days)
- •peripheral vascular disease affecting upper limbs
- •amputation of the upper limbs
- •major combined operation such as aortic surgery or carotid endarterectomy
- •descending thoracic aortic surgery
- •rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc
结局指标
主要结局
In-hospital death
时间窗: Postoperative 30 days
Myocardial infarction
时间窗: Postoperative 30 days
Stroke
时间窗: Postoperative 30 days
Respiratory failure
时间窗: Postoperative 30 days
Renal dysfunction
时间窗: Postoperative 30 days
Cardiogenic shock
时间窗: Postoperative 30 days
Gastrointestinal complication
时间窗: Postoperative 30 days
Renal failure
时间窗: Postoperative 30 days
次要结局
- Length of ICU stay(Postoperative 3 months)
- Length of postoperative hospital stay(Postoperative 3 months)