Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Completed · Not applicable

Conditions studied: Perioperative Care, Surgery--Complications, Hypothermia; Anesthesia, Myocardial Injury

In brief

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.

Key facts

Study ID: NCT03111875
Run by: The Cleveland Clinic
People needed: 5056
Starts: 2017-03-27
Expected to finish: 2022-05-17
Last updated by the study team: 2023-08-01

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Cleveland Clinic Foundation — Cleveland, Ohio, United States
PUMCH — Beijing, China
West China Hospital Sichuan Univeristy — Chengdu, China
Guangdong General Hospital — Guangzhou, China
Chinese University of Hong Kong — Hong Kong, China
Queen Mary Hospital — Hong Kong, China
Nanjing Drum Tower Hospital — Nanjing, China
FDSCC (Fudan University Shanghai — Shanghai, China
Shanghai Chest Hospital — Shanghai, China
Shanghai Oriental Hospital — Shanghai, China
Shanghai Zhongshan Hospital — Shanghai, China

Full record on ClinicalTrials.gov

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