Skip to content

Comparing Hypothermic Temperatures During Hemiarch Surgery

Thoracic Aortic Disease

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.

null

Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

University of British Columbia
University of British Columbia
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Hamilton Health Sciences
Hamilton Health Sciences
Hamilton, Ontario
Canada

Contactez l'équipe d'étude

University Health Network
University Health Network
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Fraser Health Authority
Fraser Health Authority
Surrey, British Columbia
Canada

Contactez l'équipe d'étude

Dalhousie university
Dalhousie university
Halifax, Nova Scotia
Canada

Contactez l'équipe d'étude

Health Sciences North Research Institute
Health Sciences North Research Institute
Sudbury, Ontario
Canada

Contactez l'équipe d'étude

Institut universitaire de cardiologie et de pneumologie de Québec
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
Canada

Contactez l'équipe d'étude

University of Manitoba
University of Manitoba
Winnipeg, Manitoba
Canada

Contactez l'équipe d'étude

London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contactez l'équipe d'étude

Montreal Heart Institute
Montreal Heart Institute
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Horizon Health Network
Horizon Health Network
Saint John, New Brunswick
Canada

Contactez l'équipe d'étude

University of Ottawa Heart Institute
University of Ottawa Heart Institute
Ottawa, Ontario
Canada

Contactez l'équipe d'étude

McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Étude parrainée par
Ottawa Heart Institute Research Corporation
Participants recherchés
Plus d'informations
ID de l'étude: NCT02860364