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