Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
研究概览
简要总结
Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
- •Patients who received clear information, with signed consent
- •Patients 18 to 85 years
排除标准
- •Patients under guardianship
- •No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
- •Pregnancy, lactation
- •Hemodialysis
研究组 & 干预措施
Ischemic preconditioning arm
Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.
干预措施: Ischemic preconditioning during aortic clamping (Procedure)
Control patients
Usual surgery assigned to control patients
干预措施: Procedure/Surgery: usual surgery (Procedure)
结局指标
主要结局
Myocardial damage measured by troponin level > 0.4 microgr/L (day 1)
时间窗: Day 1
Myocardial damage measured by Troponin I level \> 0.4 microg/L
次要结局
- Renal damage(Day 0, day 1, day 3 or day 5.)
- Muscle weakness(Day 0, day 1, day 3 or day 5)
- Myocardial damage measured by troponin level > 0.4 microgr/L(Day 0, 3, or 5)