Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

NCT ID: NCT03460938

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-04-01

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.

Detailed Description

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Conditions

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Myocardial Ischemia Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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RIPC

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type PROCEDURE

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote ischemic preconditioning

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective pancreaticoduodenectomy
* Age \>18

Exclusion Criteria

* No informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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dr. P. Noordzij

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Noordzij, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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St Antonius hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

References

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Reniers T, Rettig T, van Zeggeren L, Dijkstra I, Prinsze K, Molenaar I, van Santvoort H, Cremer O, Vernooij L, Noordzij P. Is chronic inflammation a risk factor for perioperative myocardial injury or heart failure in pancreatic surgery patients? BJA Open. 2025 May 19;14:100417. doi: 10.1016/j.bjao.2025.100417. eCollection 2025 Jun.

Reference Type DERIVED
PMID: 40491666 (View on PubMed)

van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, Bosma M, Molenaar Q, van Santvoort HC, Noordzij PG. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial. BJS Open. 2021 Mar 5;5(2):zrab015. doi: 10.1093/bjsopen/zrab015.

Reference Type DERIVED
PMID: 33893738 (View on PubMed)

Other Identifiers

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NL57818.100.16

Identifier Type: -

Identifier Source: org_study_id

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