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Completed

NCT Number: NCT03111875

Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

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.

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Key information

Conditions

Perioperative Care Body Temperature Changes Hypothermia Hypothermia; Anesthesia Myocardial Injury Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery--Complications

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PUMCH, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aggressive warming

Device

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 management

Device

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Deep or Organ-space Surgical Site Infection

    Time frame: 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.

  2. Number of Patients Requiring Intraoperative Transfusion

    Time frame: From surgery start to surgery end

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

  3. Duration of Hospitalization

    Time frame: 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

  4. Readmission

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

    Readmission to a hospital within a month of surgery

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: PROTECT

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Apr 13, 2017
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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