Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of AKI within the 7 days after the surgery
研究概览
简要总结
The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
详细描述
Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for total arch replacement
- •written informed consent
排除标准
- •pre-existing AKI
- •peripheral vascular disease affecting the upper limbs
- •hybrid total arch replacement
- •the history of kidney transplantation
研究组 & 干预措施
RIPC intervention
Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)
干预措施: remote ischemic preconditioning (Other)
Control
Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.
干预措施: Control (Other)
结局指标
主要结局
Incidence of AKI within the 7 days after the surgery
时间窗: Within 7 days after the surgery
AKI defined by KDIGO criteria
次要结局
- Renal replacement therapy(Within 30 days after the surgery)
- Length of intensive care unit stay(Within 30 days after the surgery)
- Incidence of severe AKI (stage 2 and stage 3)(Within 7 days after the surgery)
- In-hospital death(Within 30 days after the surgery)
- Stroke(Within 30 days after the surgery)
- Paraplegia(Within 30 days after the surgery)
- Mechanical ventilation duration(Within 30 days after the surgery)
研究者
Guyan Wang
The Chief of Infection-Control Department
Chinese Academy of Medical Sciences, Fuwai Hospital