Perioperative Myocardial Injury Clinical Trial
Official title:
Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05866874 -
Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery
|
||
| Recruiting |
NCT02573532 -
Incidence and Outcome of Perioperative Myocardial Injury After Non-cardiac Surgery
|
||
| Completed |
NCT03715712 -
NORepinephrine-Maintaining-individuaALIZEd Blood Pressure
|
N/A | |
| Completed |
NCT02687776 -
Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
|