NCT02860364

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracic Aortic Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-20
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2016-08-09
• Last updated: 2025-09-24

Locations

12 sites across 2 countries: United States, Canada