Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,204
- 试验地点
- 1
- 主要终点
- Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).
研究概览
简要总结
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.
详细描述
Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.
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
- Double (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
- •Consecutive patients >18 years of age
- •Double- or triple-vessel coronary artery disease
- •Elective isolated first-time CABG
- •Combined valve surgery + CABG
- •Written informed consent
排除标准
- •Renal failure (creatinine ≥ 200 µmol/L)
- •Peripheral vascular disease affecting upper limbs
- •Preoperative inotropic support
- •Any kind of mechanical assist device
- •Acute or recent (<4 weeks) acute coronary syndromes
- •Any PCI (<6 weeks)
- •Any reasons for preoperative cTnI elevation
- •Emergency surgery
- •Redo surgery
研究组 & 干预措施
RIPC
Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 and 10 Minutes after aortic unclamping during reperfusion of the myocardium.
干预措施: RIPC (Procedure)
RIPC
Remote ischemic preconditioning (RIPC) protocol before coronary artery bypass surgery consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion after induction of anesthesia before coronary artery bypass surgery. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and 5 and 10 Minutes after aortic unclamping during reperfusion of the myocardium.
干预措施: isoflurane+sufentanil anesthesia (Drug)
Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
干预措施: Control (Procedure)
Control
Control group: Coronary artery bypass surgery without remote ischemic preconditioning protocol
干预措施: isoflurane+sufentanil anesthesia (Drug)
结局指标
主要结局
Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).
时间窗: 72 hours postoperatively after CABG surgery
次要结局
- All-cause mortality(30 days and 1 year and complete follow-up after CABG surgery)
- Myocardial infarction(30 days and 1 year and complete follow-up after CABG surgery)
- Major adverse cardiac and cerebrovascular events (MACCE)(at 30 days and 1 year and complete follow-up after CABG surgery)
- Renal function(72 hours post CABG)
研究者
Matthias Thielmann
Matthias Thielman, MD, PhD
University Hospital, Essen