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临床试验/NCT03340181
NCT03340181Unknown不适用

Study on the Myocardial Protective Effect of RIPC in Patients Undergoing OPCABG

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
66
试验地点
1
主要终点
ICU staying time

研究概览

简要总结

The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

详细描述

66 patients scheduled for OPCABG are randomly assigned to a RIPC group(n=33) or a control group(n=33). In the RIPC group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. Patients in the control group wear the same cuff on an upper limb but no pressure is applied. Anesthetic and surgical techniques are standardized during the trial. Serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. Internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (Hif)-1a and other signalling proteins.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • serious changes in several coronary arteries that need to receive OPCABG
  • NHYA II-III
  • ASA II-III

排除标准

  • LVEF< 35%
  • acute myocardial infarction
  • multiple organ dysfunction

研究组 & 干预措施

RIPC

Experimental

4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb.

干预措施: RIPC (Other)

control

Sham Comparator

patient in control group using a blood pressure cuff on an upper limb without inflating

干预措施: RIPC (Other)

结局指标

主要结局

ICU staying time

时间窗: average of 1 year

the time patients spend in ICU after surgery

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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