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
|Condition or disease||Intervention/treatment||Phase|
|Perioperative Care Surgery--Complications Hypothermia; Anesthesia Myocardial Injury||Device: aggressive warming Device: routine thermal management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5100 participants|
|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|
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.
- 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.
- 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
- Intraoperative transfusion requirement [ Time Frame: From surgery start to surgery end ]Defined as units of red blood cells transfused
- 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
- Readmission [ Time Frame: From the end of surgery to 30 days after surgery ]Readmission to a hospital within a month of surgery
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
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|West China Hospital Sichuan Univeristy|
|Guangdong General Hospital|
|Chinese University of Hong Kong|
|Hong Kong, China|
|Queen Mary Hospital|
|Hong Kong, China|
|Nanjing Drum Tower Hospital|
|FDSCC (Fudan University Shanghai|
|Shanghai Chest Hospital|
|Shanghai Oriental Hospital|
|Shanghai Zhongshan Hospital|