Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

The Cleveland Clinic5,056 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

5,056

Conditions

Perioperative Care Surgery--Complications Hypothermia; Anesthesia Myocardial Injury

Interventions

aggressive warmingDEVICE

Patients will be pre-warming 30 minutes before induction of anesthesia and aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C.

routine thermal managementDEVICE

A forced-air cover will be positioned but will not initially be activated. The warmer will be activated when core temperature decrease to 35.5°C.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (11)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

PUMCH

Beijing, China

West China Hospital Sichuan Univeristy

Chengdu, China

Guangdong General Hospital

Guangzhou, China

Outcomes

Primary Outcomes

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

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.

Time frame: From the end of surgery to 30 days after surgery

Secondary Outcomes

Deep or Organ-space Surgical Site Infection

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.

Time frame: From the end of surgery to 30 days after surgery

Number of Patients Requiring Intraoperative Transfusion

intraoperative transfusion will be yes if this patient received more than 0 unit of red blood cells.

Time frame: From surgery start to surgery end

Data from ClinicalTrials.gov

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