Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

NCT03111875 | Completed Results DMC FDA Device

• 1 other identifier: 16-1017
• Study Type: interventional
• Target: 5,056
• Locations: 2 countries
• Sites: 11

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.

Conditions

Perioperative Care; Surgery--Complications; Hypothermia; Anesthesia; Myocardial Injury

Keywords

Hypothermia; Intraoperative warming; non-cardiac surgery; myocardial injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Deep or Organ-space Surgical Site Infection

  From the end of surgery to 30 days after surgery

• Number of Patients Requiring Intraoperative Transfusion

  From surgery start to surgery end

• Duration of Hospitalization

  From the day of surgery to the day of discharge, or 30 days after surgery if the patients is still hospitalized

• Readmission

  From the end of surgery to 30 days after surgery

Study Arms (2)

Routine thermal management

ACTIVE COMPARATOR

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

Aggressive thermal management

EXPERIMENTAL

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

Interventions

aggressive warming DEVICE

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.

Aggressive thermal management

routine thermal management DEVICE

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.

Routine thermal management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (11)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

PUMCH

Beijing, China

Location

West China Hospital Sichuan Univeristy

Chengdu, China

Location

Guangdong General Hospital

Guangzhou, China

Location

Chinese University of Hong Kong

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

FDSCC (Fudan University Shanghai

Shanghai, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Shanghai Oriental Hospital

Shanghai, China

Location

Shanghai Zhongshan Hospital

Shanghai, China

Location

Related Publications (2)

• Song S, Pei L, Chen H, Zhang Y, Sun C, Yi J, Huang Y. Analysis of hospital and payer costs of care: aggressive warming versus routine warming in abdominal major surgery. Front Public Health. 2023 Nov 2;11:1256254. doi: 10.3389/fpubh.2023.1256254. eCollection 2023.

  PMID: 38026375 DERIVED

• Sessler DI, Pei L, Li K, Cui S, Chan MTV, Huang Y, Wu J, He X, Bajracharya GR, Rivas E, Lam CKM; PROTECT Investigators. Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial. Lancet. 2022 May 7;399(10337):1799-1808. doi: 10.1016/S0140-6736(22)00560-8. Epub 2022 Apr 4.

  PMID: 35390321 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Daniel I. Sessler, MD
• Organization: Cleveland Clinic

sessled@ccf.org

216-444-4900

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: March 27, 2017
• Primary Completion: March 16, 2021
• Study Completion: May 17, 2022
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication of the main paper.
• Access Criteria: Via corresponding author,

Locations

CN (10); US (1)