Surgery--Complications Clinical Trial
— PROTECTOfficial title:
Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery
NCT number | NCT03111875 |
Other study ID # | 16-1017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 27, 2017 |
Est. completion date | May 17, 2022 |
Verified date | July 2023 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States, China,
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 |
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