Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

Not Applicable

Completed

• Conditions: Inflammatory Response; Myocardial Ischemia
• Interventions: Procedure: Remote ischemic preconditioning

• Registration Number: NCT03460938
• Lead Sponsor: St. Antonius Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-08
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-09
• Status Verified: 2019-04
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Elective pancreaticoduodenectomy
• Age >18

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC	Remote ischemic preconditioning	-

Primary Outcome Measures

Name	Time	Method
Postoperative myocardial injury.	48 hours	Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	30 days	Postoperative cardiac and noncardiac complications
Inflammatory response	48 hours	Markers of inflammation (IL6)

Trial Locations

Locations (1)

St Antonius hospital; 🇳🇱 Nieuwegein, Netherlands