The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Troponin-I
研究概览
简要总结
The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.
详细描述
When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients who undergo orthopedic surgery with duration of longer than one hour
- •Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction)
- •American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3
排除标准
- •Peripheral vascular disease involving upper or lower extremity
- •Orthopedic surgery which uses the tourniquet
研究组 & 干预措施
RIPC group
remote ischemic conditioning group with three cycles of ischemia (5 min) / reperfusion (5 min) of upper or lower limb available with automated RIPC machine using blood pressure cuff
干预措施: Remote ischemic preconditioning (Procedure)
Control group
No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available
干预措施: Sham control (Procedure)
结局指标
主要结局
Troponin-I
时间窗: postoperative day one
次要结局
- Creatinine(Postoperative day four)
- Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)(postoperative day four)
- Acute kidney injury(postoperative 48 hours)
- ST-II segment analysis by Electrocardiography(every 30 minutes during surgery)
- Oxygenation index (PaO2/FiO2)(postoperative day one)
- length of hospital stay(up to 24 week)
- length of ICU stay(up to 24 week)
- Postoperative wound infection(up to 24 week)
- Postoperative incidence of pneumonia(up to 24 week)
- Postoperative incidence of myocardial ischemic event(up to 24 week)
- Troponin-I(Postoperative day four)
- Creatinine(Immediate Postoperative)
- Troponin-I(Postoperative day two)
- Creatinine(Postoperative day one)
- Creatinine(Postoperative day two)
- Troponin-I(immediate postoperative)
- Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)(immediate postoperative)
- Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)(postoperative day one)
- Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band)(postoperative day two)
- Oxygenation index (PaO2/FiO2)(5 minutes after anesthesia induction)
- Oxygenation index (PaO2/FiO2)(5 minutes before the end of surgery)
- Oxygenation index (PaO2/FiO2)(20 minutes after the end of surgery)
研究者
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital