Comparing mild and moderate hypothermia during aortic hemiarch surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• London Health Sciences Centre
  London, Ontario, 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Making recruitment information clearer for people in thoracic aortic disease surveillance

  This project will test whether draft invitation letters, information sheets, and consent forms are clear and acceptable to adult staff and students at the University of Nottingham who read English, to improve recruitment for thoracic aortic disease surveillance research.

  Recruiting University of Nottingham · Nottingham · NCT07574151

• Feasibility check of skeletonized vs non-skeletonized left internal mammary artery harvesting in heart surgery

  This pilot test compares two ways of taking the left internal mammary artery during CABG to see which approach is feasible to study further and how it affects graft patency and patient experience.

  Recruiting Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07599553

• Improving transition of congenital heart disease care from pediatric to adult services

  This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.

  Recruiting Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07585175

• Mental health and quality of life after ICU treatment with dexmedetomidine for electrical storm

  This follows people treated for electrical storm in the ICU to see if receiving dexmedetomidine is linked to their mental health and quality of life 3–6 months later.

  Recruiting Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07368062

• Pericardial inflammation imaging to predict recurrent pericarditis

  Doctors are testing imaging tools to see if FDG PET/CT and MRI can predict which patients with recurrent pericarditis will flare again.

  Recruiting Phase 3 Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07245849

• Semaglutide to help people with type 2 diabetes quit smoking

  This pilot will test whether adding semaglutide to combination nicotine replacement helps adults with type 2 diabetes quit smoking and limits post-quit weight gain.

  Recruiting Phase 3 Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07059377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.