Comparing Hypothermic Temperatures During Hemiarch Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypothermic circulatory arrest.
- Who it may be relevant to
- Registry conditions: Thoracic Aortic Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
Overview
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.
Interventions
- Procedure 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.
Primary outcome measures
- Composite endpoint of neurologic and acute kidney injury [Time frame: Up to 90 days after surgery.]
Secondary outcome measures (12)
- Rates of Neurologic Injury [Time frame: Up to 90 days after surgery.]
- Incidence of Silent Strokes [Time frame: Up to 90 days after surgery.]
- Incidence of Acute Kidney Injury (AKI) [Time frame: Up to 90 days after surgery.]
- Incidence of Delirium [Time frame: Up to 90 days after surgery.]
- Death [Time frame: Up to 90 days after surgery.]
- Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery [Time frame: During the index procedure]
- Rates of Mediastinal re-exploration for bleeding [Time frame: Up to 90 days after surgery.]
- Incidence and quantity of perioperative blood transfusions [Time frame: Up to 90 days after surgery.]
- Incidence of prolonged Mechanical Ventilation [Time frame: Up to 90 days after surgery.]
- Perioperative Myocardial Infarction [Time frame: Up to 48 hours after surgery.]
- Length of Stay [Time frame: Up to 90 days after surgery.]
- Quality of life (SF-12) [Time frame: Up to 90 days after surgery.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 9 centers
- Kelowna General Hospital — Kelowna
- Fraser Health Authority — Surrey
- University of British Columbia — Vancouver
- Dalhousie university — Halifax
- London Health Sciences Centre — London
- University of Ottawa Heart Institute — Ottawa
- University Health Network — Toronto
- Montreal Heart Institute — Montreal
- … and 1 more center
United States · 3 centers
- Massachusetts General — Boston
- The Valley Hospital — Ridgewood
- Ohio State University Medical Center — Columbus
Publications
- 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. PMID 31815641
Identifiers
NCT: NCT02860364 · 20160408