N/A
N=5,056
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
Perioperative Care · Surgery--Complications · Hypothermia; Anesthesia · Myocardial Injury
Bottom Line
View on ClinicalTrials.gov: NCT03111875 ↗Enrolled (actual)
5,056
Serious AEs
0.9%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality — 239; 246 Participants — p=0.69
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aggressive warming (Device); routine thermal management (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality |
239; 246 | 0.69 |
| SECONDARY Deep or Organ-space Surgical Site Infection |
157; 178 | 0.25 |
| SECONDARY Number of Patients Requiring Intraoperative Transfusion |
236; 254 | 0.41 |
| SECONDARY Duration of Hospitalization |
8; 8 | — |
| SECONDARY Readmission |
135; 161 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03111875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.