Perioperative Hypothermia and Myocardial Injury After Non-cardiac Surgery



Status:Recruiting
Conditions:Cardiology, Hospital, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Other
Healthy:No
Age Range:45 - Any
Updated:4/27/2018
Start Date:April 4, 2017
End Date:December 2020
Contact:Daniel Sessler, MD
Email:SESSLED@CCF.ORG
Phone:216-444-4900

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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.

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.

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.
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-444-9950
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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mi
from
Cleveland, OH
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