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Thermal Management

aggressive warming for Hypothermia (PROTECT Trial)

N/A
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the end of surgery to 30 days after surgery
Awards & highlights

PROTECT Trial Summary

This trial will compare the effects of routine care vs. aggressive warming on cardiovascular complications.

Eligible Conditions
  • Hypothermia
  • Perioperative Care
  • Surgery Complications
  • Myocardial Injury

PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the end of surgery to 30 days after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the end of surgery to 30 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality
Secondary outcome measures
Deep or Organ-space Surgical Site Infection
Duration of Hospitalization
Number of Patients Requiring Intraoperative Transfusion
+1 more

PROTECT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aggressive thermal managementExperimental Treatment1 Intervention
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.
Group II: Routine thermal managementActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aggressive warming
2017
N/A
~5060

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,360,502 Total Patients Enrolled
6 Trials studying Hypothermia
158 Patients Enrolled for Hypothermia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The LancetJournal
Aggressive Intraoperative Warming Versus Routine Thermal Management During Non-cardiac Surgery (PROTECT): A Multicentre, Parallel Group, Superiority Trial
Sessler, Daniel I, Lijian Pei, Kai Li, Shusen Cui, Matthew T V Chan, Yuguang Huang, Jingxiang Wu, et al.. 2022. “Aggressive Intraoperative Warming Versus Routine Thermal Management During Non-cardiac Surgery (PROTECT): A Multicentre, Parallel Group, Superiority Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)00560-8.
The LancetJournal
Aggressive Intraoperative Warming Versus Routine Thermal Management During Non-cardiac Surgery (PROTECT): A Multicentre, Parallel Group, Superiority Trial
Sessler, Daniel I, Lijian Pei, Kai Li, Shusen Cui, Matthew T V Chan, Yuguang Huang, Jingxiang Wu, et al.. 2022. “Aggressive Intraoperative Warming Versus Routine Thermal Management During Non-cardiac Surgery (PROTECT): A Multicentre, Parallel Group, Superiority Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)00560-8.
clinicaltrials.govStudy
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
d sessler 2017. "Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03111875.
~625 spots leftby May 2025
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