Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Browse trials for

• Hypothermia 499
• Wounds and Injuries 5,056

Keywords

• Hypothermia
• Intraoperative warming
• non-cardiac surgery
• myocardial injury

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's enrollment of 5,056 is above the median of 80 across 351 interventional studies indexed under Hypothermia.

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Study arms

• Active comparator
  Routine thermal management

  Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An Multi-Position Upper Body Warming Blanket forced-air cover will be positioned over an appropriate non-operative site, but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further.

  Device: routine thermal management

• Experimental
  Aggressive thermal management

  Patients assigned to aggressive warming will be pre-warmed with a full-body Bair Hugger or Bair Paws cover for ≈30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to ≈43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C, using an Multi-Position Upper Body and Full Access Underbody Warming Blankets forced-air covers when clinically practical. All intravenous fluids will be warmed to body temperature.

  Device: aggressive warming

Interventions

• Deviceaggressive warming

  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.

• Deviceroutine thermal management

  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

   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

1. 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

2. 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

3. Duration of Hospitalization

   The length of hospital stay in days, censored at 30 days

   Time frame: From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized

4. Readmission

   Readmission to a hospital within a month of surgery

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

Baseline characteristics

2 further baseline measures are reported on the registry.

Publications

• 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. PubMed 35390321 ↗

Study documents

• Protocol and statistical analysis plan · Feb 1, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Investigators are welcome to propose collaborative analyses.

Supporting information: Study protocol, Sap, Icf