CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,056 enrolled
Drug / intervention
aggressive warming +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03111875
NCT03111875N/ACompleted

Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

The Cleveland Clinic·interventional·Posted Apr 13, 2017·Updated Aug 1, 2023

In Brief

A clinical study evaluating aggressive warming and routine thermal management for Perioperative Care and 3 related conditions. Completed, enrolled 5,056 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartMar 27, 2017
Primary CompletionMar 16, 2021
Study CompletionMay 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.2 years ago

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.