Clinical Trial: Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery

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.

Detailed Summary: 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.
Sponsor: The Cleveland Clinic

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: April 7, 2017
Date Started: April 4, 2017
Date Completion: December 2020
Last Updated: April 7, 2017
Last Verified: April 2017