Clinical trial NCT02860364: Comparing Hypothermic Temperatures During Hemiarch Surgery
Official title: A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Aortic Disease
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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 outcomes:
measure: Composite endpoint of neurologic and acute kidney injury
timeFrame: Up to 90 days after surgery.
Secondary outcomes:
measure: Rates of Neurologic Injury
timeFrame: Up to 90 days after surgery.
measure: Incidence of Silent Strokes
timeFrame: Up to 90 days after surgery.
measure: Incidence of Acute Kidney Injury (AKI)
timeFrame: Up to 90 days after surgery.
measure: Incidence of Delirium
timeFrame: Up to 90 days after surgery.
measure: Death
timeFrame: Up to 90 days after surgery.
measure: Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
timeFrame: During the index procedure
measure: Rates of Mediastinal re-exploration for bleeding
timeFrame: Up to 90 days after surgery.
measure: Incidence and quantity of perioperative blood transfusions
timeFrame: Up to 90 days after surgery.
measure: Incidence of prolonged Mechanical Ventilation
timeFrame: Up to 90 days after surgery.
measure: Perioperative Myocardial Infarction
timeFrame: Up to 48 hours after surgery.
measure: Length of Stay
timeFrame: Up to 90 days after surgery.
measure: Quality of life (SF-12)
timeFrame: Up to 90 days after surgery.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Surrey
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Saint John
country: Canada
facility: Horizon Health Network
state: New Brunswick
city: Halifax
country: Canada
facility: Dalhousie university
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Munir Boodhwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jabagi H, Wells G, Boodhwani M. COMMENCE trial (Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgEry): a randomized controlled trial of mild vs moderate hypothermia on patient outcomes in aortic hemiarch surgery with anterograde cerebral perfusion. Trials. 2019 Dec 9;20(1):691. doi: 10.1186/s13063-019-3713-9.