Comparing Hypothermic Temperatures During Hemiarch Surgery

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Comparing Hypothermic Temperatures During Hemiarch Surgery

Condition
Thoracic Aortic Disease
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Ridgewood

The Valley Hospital, Ridgewood, New Jersey, United States, 07450

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Durham

Duke University Hospital, Durham, North Carolina, United States, 27710

Columbus

Ohio State University Medical Center, Columbus, Ohio, United States, 43210

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Dallas

Baylor Scott & White Medical Center, Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ottawa Heart Institute Research Corporation,

Munir Boodhwani, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

2025-09