Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Renal function
研究概览
简要总结
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
详细描述
Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
排除标准
- •infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
- •Renal dysfunction
- •coronary artery disease
- •hypertension
- •peripheral vascular disease affecting the lower limb free of arteriovenous fistula
- •receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
研究组 & 干预措施
Manual Tourniquet
干预措施: Remote ischemic postconditioning (Device)
结局指标
主要结局
Renal function
时间窗: within the first 48h after cardiac surgery
次要结局
- concentration of troponin I (cTnI)(within 48h after cardiac surgery)
- Myocardial enzyme(within 48h after cardiac surgery)
- Cystatin C(within 48h after cardiac surgery)
- High-sensitivity c-reactive protein(HS-CRP)(within 48h after cardiac surgery)
研究者
Luo Wanjun
Director
Central South University