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Clinical Trials/NCT03460938
NCT03460938
Completed
N/A

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

St. Antonius Hospital1 site in 1 country90 target enrollmentMarch 8, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Ischemia
Sponsor
St. Antonius Hospital
Enrollment
90
Locations
1
Primary Endpoint
Postoperative myocardial injury.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2017
End Date
April 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr. P. Noordzij

Principal Investigator

St. Antonius Hospital

Eligibility Criteria

Inclusion Criteria

  • Elective pancreaticoduodenectomy

Exclusion Criteria

  • No informed consent

Outcomes

Primary Outcomes

Postoperative myocardial injury.

Time Frame: 48 hours

Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary Outcomes

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

Study Sites (1)

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