跳至主要内容
临床试验/NCT02720549
NCT02720549已完成不适用

The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2016年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
252
试验地点
1
主要终点
incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria

研究概览

简要总结

Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.

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, Investigator)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who are undergoing valvular heart surgery
  • •age 19-80

排除标准

  • •peripheral vascular disease with circulation deterioration
  • •Renal replacement therapy
  • •preconditioning medication
  • •Myocardiac infarction within 3 weeks
  • •active infective endocarditis
  • •high dosage steroid therapy
  • •mental retardation
  • •unlettered person

研究组 & 干预措施

post-ischemic conditioning group

Experimental

干预措施: remote ischemic postconditioning (Procedure)

valvular surgery with bypass group

Placebo Comparator

干预措施: valvular surgery with bypass (Procedure)

结局指标

主要结局

incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria

时间窗: 5 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验