Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia (MICOLON2)
Primary Purpose
Myocardial Ischemia, Inflammatory Response
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Ischemia
Eligibility Criteria
Inclusion Criteria:
- Elective pancreaticoduodenectomy
- Age >18
Exclusion Criteria:
- No informed consent
Sites / Locations
- St Antonius hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RIPC
Control
Arm Description
Outcomes
Primary Outcome Measures
Postoperative myocardial injury.
Maximum postoperative concentration of high-sensitive cardiac troponin T.
Secondary Outcome Measures
Inflammatory response
Markers of inflammation (IL6)
Postoperative complications
Postoperative cardiac and noncardiac complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03460938
Brief Title
Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia
Acronym
MICOLON2
Official Title
The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Inflammatory Response
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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 Outcome Measure Information:
Title
Postoperative myocardial injury.
Description
Maximum postoperative concentration of high-sensitive cardiac troponin T.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Inflammatory response
Description
Markers of inflammation (IL6)
Time Frame
48 hours
Title
Postoperative complications
Description
Postoperative cardiac and noncardiac complications
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective pancreaticoduodenectomy
Age >18
Exclusion Criteria:
No informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Noordzij, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Antonius hospital
City
Nieuwegein
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33893738
Citation
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.
Results Reference
derived
Learn more about this trial
Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia
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