Trials / Completed
CompletedNCT03111875
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5,056 (actual)
- Sponsor
- The Cleveland Clinic · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | aggressive 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. |
| DEVICE | routine 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. |
Timeline
- Start date
- 2017-03-27
- Primary completion
- 2021-03-16
- Completion
- 2022-05-17
- First posted
- 2017-04-13
- Last updated
- 2023-08-01
- Results posted
- 2023-08-01
Locations
11 sites across 2 countries: United States, China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03111875. Inclusion in this directory is not an endorsement.