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Completed

NCT Number: NCT03460938

Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Antonius hospital

Nieuwegein, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective pancreaticoduodenectomy
  • Age >18

Exclusion criteria

  • No informed consent

Treatment and study plan

Remote ischemic preconditioning

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.

Primary outcomes

  1. Postoperative myocardial injury.

    Time frame: 48 hours

    Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary outcomes

  1. Inflammatory response

    Time frame: 48 hours

    Markers of inflammation (IL6)

  2. Postoperative complications

    Time frame: 30 days

    Postoperative cardiac and noncardiac complications

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: MICOLON2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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