Ischaemic PReconditioning In Non Cardiac surgEry
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 1,217
- 试验地点
- 55
- 主要终点
- cardiac troponin
研究概览
简要总结
Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.
Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.
The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •intermedial and high risk non cardiac surgery
- •general anesthesia
- •ongoing or recently suspended antiplatelet therapy
排除标准
- •pregnancy
- •planned locoregional anesthesia without general anesthesia
- •unstable or ongoing angina
- •recent (< 1 month) or ongoing acute myocardial infarction
- •inclusion in other randomised controlled studies in the previous 30 days
- •peripheral vascular disease affecting the upper limbs
- •cardiac surgery
研究组 & 干预措施
remote ischemic preconditioning
Three cycles of 5 minutes ischemia will be applied to the upper left arm (or right arm or legs if the left arm will not be deemed suitable by the attending physician), achieved by inflation of a blood-pressure cuff to 200 mm Hg, followed by 5 minutes reperfusion while the cuff will be deflated.
干预措施: Remote ischemic preconditioning (Other)
no ischemic preconditioning
The cuff will be placed around the arm but not inflated.
干预措施: no ischemic preconditioning (Other)
结局指标
主要结局
cardiac troponin
时间窗: Hospital - approximately 1 week
elevation of cardiac troponin after non-cardiac surgery
次要结局
未报告次要终点
研究者
Giovanni Landoni
MD, Associate Professor
Università Vita-Salute San Raffaele
