Comparing Hypothermic Temperatures During Hemiarch Surgery

NCT02860364 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Heart Institute Research Corporation

Phase

Not applicable

Started

2018-02-20

Last updated

2025-09-24

Condition(s) studied

Thoracic Aortic Disease

Investigational drug(s) / intervention(s)

Hypothermic circulatory arrest

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Composite endpoint of neurologic and acute kidney injury — Up to 90 days after surgery.
The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.

Trial sites (12)

Facility	City	Region	Status
Massachusetts General	Boston	Massachusetts	Recruiting
The Valley Hospital	Ridgewood	New Jersey	Recruiting
Ohio State University Medical Center	Columbus	Ohio	Recruiting
Kelowna General Hospital	Kelowna	British Columbia	Recruiting
Fraser Health Authority	Surrey	British Columbia	Recruiting
University of British Columbia	Vancouver	British Columbia	Not Yet Recruiting
Dalhousie university	Halifax	Nova Scotia	Not Yet Recruiting
London Health Sciences Centre	London	Ontario	Recruiting
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting
University Health Network	Toronto	Ontario	Recruiting
Montreal Heart Institute	Montreal	Quebec	Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02860364 on ClinicalTrials.gov ↗ ← All trials in Canada