Comparing Hypothermic Temperatures During Hemiarch Surgery
ConditionThoracic Aortic Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Elective aortic hemiarch surgery
Planned unilateral selective anterograde cardioplegia
Anticipated lower body arrest time of < 20 minutes
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hypothermic circulatory arrest
Procedure/SurgeryDuring cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
Treatment groups
282 Participants
are divided into 2 treatment groupsGroup A: Mild Hypothermic Circulatory ArrestExperimental treatment 1 intervention
Group B: Moderate Hypothermic Circulatory ArrestActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov