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Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03460938
Acronym
MICOLON2
Enrollment
90
Registered
2018-03-09
Start date
2017-03-08
Completion date
2019-04-01
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response, Myocardial Ischemia

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.

Interventions

PROCEDURERemote 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.

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective pancreaticoduodenectomy * Age \>18

Exclusion criteria

* No informed consent

Design outcomes

Primary

MeasureTime frameDescription
Postoperative myocardial injury.48 hoursMaximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary

MeasureTime frameDescription
Inflammatory response48 hoursMarkers of inflammation (IL6)
Postoperative complications30 daysPostoperative cardiac and noncardiac complications

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026