Remote Ischaemic Preconditioning for Heart Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,400
- 试验地点
- 10
- 主要终点
- Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
研究概览
简要总结
The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.
详细描述
Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing heart surgery on cardiopulmonary bypass
排除标准
- •age < 18
- •Emergency cases
- •left ventricular ejection fraction less than 30%
- •current atrial fibrillation
- •Inability to give informed consent
- •preoperative use of inotropics or mechanical assist device
- •severe liver, renal and pulmonary disease
- •recent myocardial infarction (within 7 days)
- •recent systemic infection or sepsis (within 7 days)
- •severe stroke (within 2 months)
- •peripheral vascular disease affecting upper limbs
- •previous serious psychiatric disorders (e.g. schizophrenia, dementia)
- •concomitant carotid endarterectomy
- •rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy
结局指标
主要结局
Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
时间窗: In-hospital
Time frame until hospital discharge
次要结局
- length of stay on the intensive care unit(Postoperative during hospital stay)
- total hospital stay(hospital discharge)
- Occurence of any component of the composite outcome(Postoperative hospital discharge, 3 months, 12 months)
- new onset of atrial fibrillation(In-hospital)
- Delirium(Postoperative 24, 48, 72, 96 hrs)
研究者
Patrick Meybohm
Prof. Dr. Patrick Meybohm
University Hospital Schleswig-Holstein