Overview

This trial is active, not recruiting.

Condition perioperative myocardial injury
Treatments remote ischaemic preconditioning, control
Sponsor London Surgical Research Group
Collaborator Royal Berkshire NHS Foundation Trust
Start date June 2013
End date March 2016
Trial size 84 participants
Trial identifier NCT01850927, LSRG-002

Summary

Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Patients will receive remote ischaemic preconditioning prior to surgery. After the induction of anaesthesia, a blood pressure cuff will be placed on an upper arm and inflated to 200mmHg for 5 minutes, then deflated for 5 minutes, repeated for a total of 3 inflation-deflation cycles.
remote ischaemic preconditioning
(Sham Comparator)
Patients will have the same procedure as for the intervention group, however the blood pressure cuff valve will be left open throughout the 30 minute treatment. Patients will be kept under anaesthesia for this additional time.
control

Primary Outcomes

Measure
Peak post-operative troponin (ng/L)
time frame: At 6-12, 24, 48, 72h

Secondary Outcomes

Measure
Any major adverse cardiovascular events
time frame: 30 days
Any serious surgical complications
time frame: 30 days
Area-under-the-curve post-operative troponin (ng/L)
time frame: 72 hours
Positive post-operative troponin (binary endpoint, >20ng/L)
time frame: 72 hours

Eligibility Criteria

Male or female participants at least 45 years old.

Inclusion Criteria: - is ≥ 45 years old; - is undergoing elective major colorectal or upper GI surgery. Exclusion Criteria - Diabetic patients that are taking glibenclamide medication - Patients with upper limb peripheral vascular disease, including those with arteriovenous fistula for dialysis - Untreated hypertension (defined as two or more readings >180mmHg systolic on admission for surgery) - Current participation in any study investigating troponin levels or ischaemic preconditioning - Unable or lacks capacity to give informed consent to participation

Additional Information

Official title Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
Principal investigator Stefan S Antonowicz, MBChB MRCS
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by London Surgical Research Group.