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Trial record 87 of 245 for:    "ottawa heart institute"

Comparing Hypothermic Temperatures During Hemiarch Surgery (COMMENCE)

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ClinicalTrials.gov Identifier: NCT02860364
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thoracic Aortic Disease Procedure: Hypothermic circulatory arrest Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mild Hypothermic Circulatory Arrest
During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
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.

Active Comparator: Moderate Hypothermic Circulatory Arrest
During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.
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 :
  1. Composite endpoint of neurologic and acute kidney injury [ Time Frame: 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 :
  1. Rates of Neurologic Injury [ Time Frame: 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.

  2. Incidence of Silent Strokes [ Time Frame: 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.

  3. Incidence of Acute Kidney Injury (AKI) [ Time Frame: 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.

  4. Incidence of Delirium [ Time Frame: 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.

  5. Death [ Time Frame: 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

  6. 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 ]
    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.

  7. Rates of Mediastinal re-exploration for bleeding [ Time Frame: 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.

  8. Incidence and quantity of perioperative blood transfusions [ Time Frame: 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

  9. Incidence of prolonged Mechanical Ventilation [ Time Frame: 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.

  10. Perioperative Myocardial Infarction [ Time Frame: 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.

  11. Length of Stay [ Time Frame: 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.

  12. Quality of life (SF-12) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860364


Contacts
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Contact: Jabagi Habib, MD 613-696-7295 hjabagi@ottawaheart.ca
Contact: Jacqueline Fortier, MSc 613-696-7000 ext 18329 jfortier@ottawaheart.ca

Locations
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Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Clare Russell    4039442515    clare.russell@ahs.ca   
Principal Investigator: Jehangir Appoo, MD         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Munir Boodhwani, MD Ottawa Heart Institute Research Corporation

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02860364     History of Changes
Other Study ID Numbers: 20160408
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Diseases
Vascular Diseases
Cardiovascular Diseases