Clinical trial NCT03111875: Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
Official title: Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Care
Surgery--Complications
Hypothermia; Anesthesia
Myocardial Injury
Keywords: Hypothermia
Intraoperative warming
non-cardiac surgery
myocardial injury
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 5056
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 outcomes:
measure: 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
Secondary outcomes:
measure: Deep or Organ-space Surgical Site Infection
timeFrame: From the end of surgery to 30 days after surgery
measure: Number of Patients Requiring Intraoperative Transfusion
timeFrame: From surgery start to surgery end
measure: Duration of Hospitalization
timeFrame: From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized
measure: Readmission
timeFrame: From the end of surgery to 30 days after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Beijing
country: China
facility: PUMCH
city: Chengdu
country: China
facility: West China Hospital Sichuan Univeristy
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: FDSCC (Fudan University Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References:
citation: Sessler DI, Pei L, Li K, Cui S, Chan MTV, Huang Y, Wu J, He X, Bajracharya GR, Rivas E, Lam CKM; PROTECT Investigators. Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial. Lancet. 2022 May 7;399(10337):1799-1808. doi: 10.1016/S0140-6736(22)00560-8. Epub 2022 Apr 4.