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NCT02860364NARecruiting

Comparing Hypothermic Temperatures During Hemiarch Surgery

Ottawa Heart Institute Research Corporation

Start Date

2/20/2018

Completion Date

12/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age ≥ 18 years * Elective aortic hemiarch surgery * Planned unilateral selective anterograde cardioplegia * Anticipated lower body arrest time of \< 20 minutes * Able to provide written informed consent Exclusion Criteria: * Surgery for acute aortic dissection or emergent operations * Total arch replacement * Inability to perform unilateral selective anterograde cerebral perfusion (uSACP) * Patients with known/documented coagulopathy * Patients with cold agglutinin disease or those that test positive on routine preop screening * Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon * Severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without neurological deficits; or carotid stenosis \> 50% with neurological deficits; or previous carotid endarterectomy or stenting * Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 * Use of an investigational drug or device at time of enrollment * Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Interventions

PROCEDURE

Hypothermic circulatory arrest

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Conditions

Thoracic Aortic Disease

Locations

Massachusetts General

Boston, Massachusetts 02114

United States

The Valley Hospital

Ridgewood, New Jersey 07450

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

Kelowna General Hospital

Kelowna, British Columbia V1Y 1T2

Canada

Fraser Health Authority

Surrey, British Columbia V3T 0H1

Canada

University of British Columbia

Vancouver, British Columbia V6Z 1Y6

Canada

Dalhousie university

Halifax, Nova Scotia B3H 3A7

Canada

London Health Sciences Centre

London, Ontario N6A 5A5

Canada

University of Ottawa Heart Institute

Ottawa, Ontario K1Y 4W7

Canada

University Health Network

Toronto, Ontario M5G 2N2

Canada

Montreal Heart Institute

Montreal, Quebec H1T 1C8

Canada

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec G1V 4G5

Canada