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临床试验/NCT03460938
NCT03460938已完成不适用

The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年3月8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
90
试验地点
1
主要终点
Postoperative myocardial injury.

研究概览

简要总结

High-risk abdominal surgery is frequently complicated by postoperative complications, such as sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is associated with a protective effect on the heart. The effect of RIPC in abdominal surgery patients is unknown.

Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic sugery.

Study design: Randomised controlled parallel group mono-center pilot study.

Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St. Antonius Hospital (45 in the intervention group and 45 in the control group).

Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is placed on the upper extremity for 30 minutes.

Primary study parameters/outcome of the study: Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and renal injury, postoperative complications during 30 days, length of stay and hospital mortality.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Elective pancreaticoduodenectomy

排除标准

  • No informed consent

研究组 & 干预措施

RIPC

Experimental

干预措施: Remote ischemic preconditioning (Procedure)

Control

No Intervention

结局指标

主要结局

Postoperative myocardial injury.

时间窗: 48 hours

Maximum postoperative concentration of high-sensitive cardiac troponin T.

次要结局

  • Postoperative complications(30 days)
  • Inflammatory response(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. P. Noordzij

Principal Investigator

St. Antonius Hospital

研究点 (1)

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