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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Hypothermic Circulatory Arrest | Experimental | During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest. |
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| Moderate Hypothermic Circulatory Arrest | Active Comparator | During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypothermic circulatory arrest | Procedure | During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 90 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 90 days after surgery. |
| Incidence of Silent Strokes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jehangir Appoo, MD | Contact | 403-944-2515 | jappoo@ucalgary.ca | |
| Alice Black, BSc | Contact | 613-696-7230 | alblack@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Munir Boodhwani, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31815641 | Derived | 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. |
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Individual participant data will not be made available to other researchers.
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| ID | Term |
|---|---|
| D050792 | Circulatory Arrest, Deep Hypothermia Induced |
| ID | Term |
|---|---|
| D006324 | Heart Arrest, Induced |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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. |
| 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. | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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. | Up to 90 days after surgery. |
| The Valley Hospital | Recruiting | Ridgewood | New Jersey | 07450 | United States |
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| Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Kelowna General Hospital | Recruiting | Kelowna | British Columbia | V1Y 1T2 | Canada |
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| Fraser Health Authority | Recruiting | Surrey | British Columbia | V3T 0H1 | Canada |
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| University of British Columbia | Not yet recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| Dalhousie university | Not yet recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5A5 | Canada |
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| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
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| University Health Network | Recruiting | Toronto | Ontario | M5G 2N2 | Canada |
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| Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T 1C8 | Canada |
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| Institut universitaire de cardiologie et de pneumologie de Québec | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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| D019616 | Thoracic Surgical Procedures |