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Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03111875
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Perioperative Care Surgery--Complications Hypothermia; Anesthesia Myocardial Injury Device: aggressive warming Device: routine thermal management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: To maintain blinding, the anesthesia record will be sealed in an opaque envelope before patients leave the post-anesthesia care unit. The envelope will be marked "Do not open until [date 35 days after surgery]." Some hospitals will have electronic records; in those cases, we will ask investigators evaluating postoperative outcomes not to access the anesthesia record.
Primary Purpose: Supportive Care
Official Title: Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : April 18, 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Routine thermal management
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.
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.

Experimental: Aggressive thermal management
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.
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.




Primary Outcome Measures :
  1. A composite of myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, and all-cause mortality [ Time Frame: From the end of surgery to 30 days after surgery ]
    Outcomes will be centrally adjudicated.


Secondary Outcome Measures :
  1. Deep or organ-space surgical site infection [ Time Frame: From the end of surgery to 30 days after surgery ]
    Surgical site infection is defined by Center for Disease Control criteria

  2. Intraoperative transfusion requirement [ Time Frame: From surgery start to surgery end ]
    Defined as units of red blood cells transfused

  3. Duration of hospitalization [ Time Frame: From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized ]
    The length of hospital stay in days, censored at 30 days

  4. Readmission [ Time Frame: From the end of surgery to 30 days after surgery ]
    Readmission to a hospital within a month of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111875


Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
China
PUMCH
Beijing, China
West China Hospital Sichuan Univeristy
Chengdu, China
Guangdong General Hospital
Guangzhou, China
Chinese University of Hong Kong
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Nanjing Drum Tower Hospital
Nanjing, China
FDSCC (Fudan University Shanghai
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Oriental Hospital
Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, China
Sponsors and Collaborators
The Cleveland Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: d sessler, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03111875    
Other Study ID Numbers: 16-1017
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators are welcome to propose collaborative analyses.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Upon publication of the main paper.
Access Criteria: Via corresponding author,

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by d sessler, The Cleveland Clinic:
Hypothermia
Intraoperative warming
non-cardiac surgery
myocardial injury
Additional relevant MeSH terms:
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Hypothermia
Wounds and Injuries
Body Temperature Changes