Comparing Hypothermic Temperatures During Hemiarch Surgery

Conditions

• Thoracic Aortic Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Feb 20, 2018

Status verified

Sep 2025

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

282 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mild Hypothermic Circulatory Arrest
  During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
• Active Comparator: Moderate Hypothermic Circulatory Arrest
  During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.

Primary Outcome Measure

Composite endpoint of neurologic and acute kidney injury [ Time Frame: Up to 90 days after surgery. ]

Central Contacts

• Jehangir Appoo, MD
  403-944-2515
  [email protected]
• Alice Black, BSc
  613-696-7230
  [email protected]

Locations (3)

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