Comparing mild and moderate hypothermia during aortic hemiarch surgery
A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
This study is testing if keeping patients at a slightly warmer temperature during heart surgery can help them recover better and spend less time on the heart-lung machine compared to a cooler temperature.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 282 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 12 sites (Boston, Massachusetts and 11 other locations) |
| Trial ID | NCT02860364 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of mild (32°C) versus moderate (26°C) hypothermia during elective aortic hemiarch surgery. The study aims to determine if mild hypothermia can reduce the duration of cardiopulmonary bypass time and improve patient outcomes by minimizing morbidity and mortality associated with longer bypass times. Patients will be randomized to receive either temperature treatment during the surgical procedure, allowing for a direct comparison of the two approaches. The trial focuses on patients undergoing planned unilateral selective anterograde cardioplegia with anticipated lower body arrest times of less than 20 minutes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for elective aortic hemiarch surgery.
Not a fit: Patients with acute aortic dissection, those requiring total arch replacement, or individuals with severe neurological impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing aortic hemiarch surgery.
How similar studies have performed: Other studies have explored hypothermic techniques in cardiac surgery, suggesting potential benefits, but this specific comparison of mild versus moderate hypothermia is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 11 other locations
- Massachusetts General — Boston, Massachusetts, United States (Recruiting)
- The Valley Hospital — Ridgewood, New Jersey, United States (Recruiting)
- Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Kelowna General Hospital — Kelowna, British Columbia, Canada (Recruiting)
- Fraser Health Authority — Surrey, British Columbia, Canada (Recruiting)
- University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Dalhousie university — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Institut universitaire de cardiologie et de pneumologie de Québec — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Munir Boodhwani, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Jehangir Appoo, MD
- Email: jappoo@ucalgary.ca
- Phone: 403-944-2515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.