Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Surgery--Complications Clinical Trial

— PROTECT  

Official title:

Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111875
• Other study ID #: 16-1017
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: May 17, 2022

Study information

• Verified date: July 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5056
• Est. completion date: May 17, 2022
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia
• Myocardial Injury
• Perioperative Care
• Surgery--Complications
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
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
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Composite Outcome Consisted of Myocardial Injury After Non-cardiac Surgery (MINS), Non-fatal Cardiac Arrest, and All-cause Mortality	The primary outcome was a composite of myocardial injury after non-cardiac surgery, non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery. Myocardial injury was diagnosed when available troponin concentrations exceeded generation-specific and type-specific thresholds and were apparently of ischaemic origin (ie, no other obvious cause for artifactual elevation). We used the following thresholds based on available literature at time of adjudication: 1) non-high-sensitivity (fourth-generation) troponin T =0.03 ng/ml2; 2) high-sensitivity troponin T =65 ng/L; or high-sensitivity troponin T 20-64 ng/L and an increase =5 ng/L from baseline3; 3) high-sensitivity troponin I (Abbott assay) is =75 ng/L4; 4) high-sensitivity troponin I (Siemens assay) is; =60 ng/L5; or, 5) troponin I (other assays) greater than local 99th percentiles. Myocardial infarction diagnosis required both troponin elevation and at least one diagnostic symptom or sign.	From the end of surgery to 30 days after surgery
Secondary	Deep or Organ-space Surgical Site Infection	Surgical site infection is defined by US Centers for Disease Control and Prevention criteria. It is consisted of superficial infection, deep infection, and organ-space infection.; Superficial infection: Infection involves only skin or subcutaneous tissue of the incision.; Deep infection: Infection appears to be related to the operation and infection involves deep soft tissues (e.g., fascial and muscle layers) of the incision.; Organ-space infection: Infection involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was opened or manipulated during an operation.	From the end of surgery to 30 days after surgery
Secondary	Number of Patients Requiring Intraoperative Transfusion	intraoperative transfusion will be yes if this patient received more than 0 unit of red blood cells.	From surgery start to surgery end
Secondary	Duration of Hospitalization	The length of hospital stay in days, censored at 30 days	From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized
Secondary	Readmission	Readmission to a hospital within a month of surgery	From the end of surgery to 30 days after surgery