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Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia (MICOLON2)

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ClinicalTrials.gov Identifier: NCT03460938
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
dr. P. Noordzij, 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.


Condition or disease Intervention/treatment Phase
Myocardial Ischemia Inflammatory Response Procedure: Remote ischemic preconditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
Actual Study Start Date : March 8, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RIPC Procedure: 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.

No Intervention: Control



Primary Outcome Measures :
  1. Postoperative myocardial injury. [ Time Frame: 48 hours ]
    Maximum postoperative concentration of high-sensitive cardiac troponin T.


Secondary Outcome Measures :
  1. Inflammatory response [ Time Frame: 48 hours ]
    Markers of inflammation (IL6)

  2. Postoperative complications [ Time Frame: 30 days ]
    Postoperative cardiac and noncardiac complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective pancreaticoduodenectomy
  • Age >18

Exclusion Criteria:

  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460938


Locations
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Netherlands
St Antonius hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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Principal Investigator: Peter Noordzij, MD St. Antonius Hospital
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Responsible Party: dr. P. Noordzij, Principal Investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03460938    
Other Study ID Numbers: NL57818.100.16
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases