Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Not Applicable

Completed

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

Brief 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.

Detailed Description: Hypothermia increases sympathetic activation, promotes tachycardia, and causes hypertension - all of which may increase the risk of myocardial injury. Moderate perioperative hypothermia is now uncommon, but mild hyperthermia (≈35.5°C) remains common. Whether aggressive warming to a truly normothermic level (≈37°C) improves outcomes remains unknown.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality	From the end of surgery to 30 days after surgery	The primary outcome was a composite of myocardial injury after non-cardiac surgery, non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. Myocardial injury was diagnosed when available troponin concentrations exceeded generation-specific and type-specific thresholds and were apparently of ischaemic origin (ie, no other obvious cause for artifactual elevation). We used the following thresholds based on available literature at time of adjudication: 1) non-high-sensitivity (fourth-generation) troponin T ≥0.03 ng/ml2; 2) high-sensitivity troponin T ≥65 ng/L; or high-sensitivity troponin T 20-64 ng/L and an increase ≥5 ng/L from baseline3; 3) high-sensitivity troponin I (Abbott assay) is ≥75 ng/L4; 4) high-sensitivity troponin I (Siemens assay) is ≥60 ng/L5; or, 5) troponin I (other assays) greater than local 99th percentiles. Myocardial infarction diagnosis required both troponin elevation and at least one diagnostic symptom or sign.

Secondary Outcome Measures

Name	Time	Method
Deep or Organ-space Surgical Site Infection	From the end of surgery to 30 days after surgery	Surgical site infection is defined by US Centers for Disease Control and Prevention criteria. It is consisted of superficial infection, deep infection, and organ-space infection. Superficial infection: Infection involves only skin or subcutaneous tissue of the incision. Deep infection: Infection appears to be related to the operation and infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision. Organ-space infection: Infection involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was opened or manipulated during an operation.
Duration of Hospitalization	From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized	The length of hospital stay in days, censored at 30 days
Number of Patients Requiring Intraoperative Transfusion	From surgery start to surgery end	intraoperative transfusion will be yes if this patient received more than 0 unit of red blood cells.
Readmission	From the end of surgery to 30 days after surgery	Readmission to a hospital within a month of surgery

Locations (11): 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
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Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States