Comparing Hypothermic Temperatures During Hemiarch Surgery

Launched by OTTAWA HEART INSTITUTE RESEARCH CORPORATION · Aug 8, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of different temperatures during a specific heart surgery called aortic hemiarch surgery, which is used to treat thoracic aortic disease. The researchers want to see if keeping the body at a slightly warmer temperature (32°C) compared to a cooler temperature (26°C) during a technique called hypothermic circulatory arrest can help reduce surgery time on a heart-lung machine and lower the risk of complications like bleeding or brain injury.

To be eligible for the trial, participants must be at least 18 years old and scheduled for elective aortic hemiarch surgery. They should be able to provide written consent and have certain health conditions that allow for this type of surgery. If someone is interested in participating, they can expect to be randomly assigned to one of the two temperature groups during their surgery. This trial is currently recruiting participants, and it aims to gather important information that could make heart surgeries safer in the future.

Gender

ALL

Eligibility criteria

• 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