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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
282
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
Massachusetts General
Boston, Massachusetts, United States
RECRUITINGThe Valley Hospital
Ridgewood, New Jersey, United States
RECRUITINGOhio State University Medical Center
Columbus, Ohio, United States
RECRUITINGKelowna General Hospital
Kelowna, British Columbia, Canada
RECRUITINGFraser Health Authority
Surrey, British Columbia, Canada
RECRUITINGUniversity of British Columbia
Vancouver, British Columbia, Canada
NOT_YET_RECRUITINGDalhousie university
Halifax, Nova Scotia, Canada
NOT_YET_RECRUITINGLondon Health Sciences Centre
London, Ontario, Canada
RECRUITINGUniversity of Ottawa Heart Institute
Ottawa, Ontario, Canada
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITING...and 2 more locations
Composite endpoint of neurologic and acute kidney injury
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.
Time frame: Up to 90 days after surgery.
Rates of Neurologic Injury
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.
Time frame: Up to 90 days after surgery.
Incidence of Silent Strokes
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.
Time frame: Up to 90 days after surgery.
Incidence of Acute Kidney Injury (AKI)
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.
Time frame: Up to 90 days after surgery.
Incidence of Delirium
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.
Time frame: Up to 90 days after surgery.
Death
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of 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
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.
Time frame: During the index procedure
Rates of Mediastinal re-exploration for bleeding
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.
Time frame: Up to 90 days after surgery.
Incidence and quantity of perioperative blood transfusions
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
Time frame: Up to 90 days after surgery.
Incidence of prolonged Mechanical Ventilation
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.
Time frame: Up to 90 days after surgery.
Perioperative Myocardial Infarction
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.
Time frame: Up to 48 hours after surgery.
Length of Stay
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.
Time frame: Up to 90 days after surgery.
Quality of life (SF-12)
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.
Time frame: Up to 90 days after surgery.
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