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NCT Number: NCT02860364

Comparing Hypothermic Temperatures During Hemiarch Surgery

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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Key information

Conditions

Thoracic Aortic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kelowna General Hospital, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Black, BSc

CONTACT

[email protected]

613-696-7230

Jehangir Appoo, MD

CONTACT

[email protected]

403-944-2515

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion

Acronym: TITAN:COMMENCE

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Aug 9, 2016
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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