Comparing Hypothermic Temperatures During Hemiarch Surgery
- Conditions
- Thoracic Aortic Disease
- Interventions
- Procedure: Hypothermic circulatory arrest
- Registration Number
- NCT02860364
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 282
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate Hypothermic Circulatory Arrest Hypothermic circulatory arrest During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest. Mild Hypothermic Circulatory Arrest Hypothermic circulatory arrest During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
- Primary Outcome Measures
Name Time Method Composite endpoint of neurologic and acute kidney injury Up to 90 days after surgery. The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.
- Secondary Outcome Measures
Name Time Method Rates of Mediastinal re-exploration for bleeding Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.
Length of Stay Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.
Rates of Neurologic Injury Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA) and permanent neurological dysfunction (PND) or stroke.
Incidence of Silent Strokes Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of silent strokes, defined as infarctions identified during magnetic resonance imaging (MRI) in patients without neurologic symptoms.
Incidence of Acute Kidney Injury (AKI) Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of acute kidney injury (AKI), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase \>= 27umol/L with urine output \<0.5mL/kg/hour for 6-12 hours.
Incidence of Delirium Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of delirium, using the Confusion Assessment Method (CAM). The Confusion Assessment Method defines delirium as the presence of acute changes in mental status with fluctuating course, plus inattention and the presence of either disorganized thinking OR altered level of consciousness.
Death Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery During the index procedure Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the length of time that the patient remains on cardiopulmonary bypass.
Incidence of prolonged Mechanical Ventilation Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of mechanical ventilation. Mechanical ventilation will be defined as use of a mechanical ventilator ≥48 hours.
Incidence and quantity of perioperative blood transfusions Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the number and quantity of perioperative blood transfusions
Perioperative Myocardial Infarction Up to 48 hours after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of perioperative myocardial infarction. This will be clinically diagnosed using a combination of electrocardiographic (new Q wave on 12 lead ECG) and/or biochemical (TnI \> 45 ng/L) markers.
Quality of life (SF-12) Up to 90 days after surgery. Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the patient's quality of life measured using the Short Form (SF) 12 questionnaire.
Trial Locations
- Locations (21)
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Horizon Health Network
🇨🇦Saint John, New Brunswick, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Fraser Health Authority
🇨🇦Surrey, British Columbia, Canada
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Massachusetts General
🇺🇸Boston, Massachusetts, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Scott & White Medical Center
🇺🇸Dallas, Texas, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Dalhousie university
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Health Sciences North Research Institute
🇨🇦Sudbury, Ontario, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
🇨🇦Québec, Quebec, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada