CompletedNot Applicable

Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

United States, China5,056 participantsStarted 2017-03-27

Plain-language summary

We propose to test the hypothesis that aggressive warming reduces the incidence of major cardiovascular complications, compared to routine care. Half of the participants will be randomly assigned to routine care (core temperature ≈35.5°C), while the other half will receive aggressive warming (\>37°C core temperature) in a multi-center trial.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Scheduled for major noncardiac surgery expected to last 2-6 hours; * Having general anesthesia; * Expected to require at least overnight hospitalization; * Expected to have \>50% of the anterior skin surface available for warming; * Have at least one of the following risk factors: a. Age over 65 years; b. History of peripheral vascular surgery; c. History of coronary artery disease; d. History of stroke or transient ischemic attack; e. Serum creatinine \>175 µmal/L (\>2.0 mg/dl); f. Diabetes requiring medication; e. Hypertension requiring medication; g. Current smoking. Exclusion Criteria: * Have a clinically important coagulopathy in the judgement of the attending anesthesiologist; * Are septic (clinical diagnosis by the attending anesthesiologist); * Body mass index exceeding 30 kg/m2; * End-stage renal disease requiring dialysis; * Surgeon believes patient to be at particular infection risk.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality

Timeframe: From the end of surgery to 30 days after surgery

Trial details

NCT IDNCT03111875

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-16

Results submitted2023-01-23

View on ClinicalTrials.gov More Perioperative Care trials