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Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

NCT03111875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5056

Last updated 2023-08-01

Study results available
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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.

Conditions

  • Perioperative Care
  • Surgery--Complications
  • Hypothermia; Anesthesia
  • Myocardial Injury

Interventions

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2021-03-16
Completion
2022-05-17
FDA Device
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111875 on ClinicalTrials.gov