Clinical Trial: Mild vs Moderate Hypothermia in Aortic Hemiarch Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Ottawa Heart Institute Research Corporation

Current Primary Outcome: 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: index procedure ]

The amount of time that the patient remains on cardiopulmonary bypass.


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the safety of mild versus moderate hypothermia during aortic hemiarch surgery [ Time Frame: Up to 90 days after surgery. ]

The comparative safety will be evaluated using a composite endpoint which includes the following events: death; mediastinal reexploration for bleeding; reduced perioperative blood transfusions; acute kidney injury; postoperative mechanical ventilation; neurologic dysfunction and/or stroke; myocardial infarction; length of stay in ICU and in hospital; and quality of life.


Original Secondary Outcome: Same as current

Information By: Ottawa Heart Institute Research Corporation

Dates:
Date Received: August 4, 2016
Date Started: June 2017
Date Completion: September 2019
Last Updated: April 24, 2017
Last Verified: April 2017