Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Ischemia, Inflammatory Response

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective pancreaticoduodenectomy Age >18 Exclusion Criteria: No informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC<br> | Procedure: Remote ischemic preconditioning<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative myocardial injury. | Maximum postoperative concentration of high-sensitive cardiac troponin T. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response | Markers of inflammation (IL6) | 48 hours | 
| Postoperative complications | Postoperative cardiac and noncardiac complications | 30 days |