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RECRUITING
NCT02860364
NA

Comparing Hypothermic Temperatures During Hemiarch Surgery

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

Summary

Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.

Official title: A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

282

Start Date

2018-02-20

Completion Date

2030-12

Last Updated

2025-09-24

Healthy Volunteers

No

Interventions

PROCEDURE

Hypothermic circulatory arrest

During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.

Locations (12)

Massachusetts General

Boston, Massachusetts, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Kelowna General Hospital

Kelowna, British Columbia, Canada

Fraser Health Authority

Surrey, British Columbia, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Dalhousie university

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada