Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

Completed · Not applicable

Conditions studied: Cognition Disorders

In brief

In this study the investigator will randomize 273 subjects to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with circulatory arrest. The primary purpose of this study is to determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest in participants.

Key facts

Study ID

NCT02834065

Run by

Duke University

People needed

273

Starts

2016-07-28

Expected to finish

2023-02-01

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi- or total arch replacement via median sternotomy

You may not qualify if…

• < 18 years of age
• History of symptomatic cerebrovascular disease, eg, prior stroke with residual deficit
• Alcoholism (> 2 drinks/day)
• Psychiatric illness (any clinical diagnoses requiring therapy)
• Drug abuse (any illicit drug use in the past 3 months)
• Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
• Severe pulmonary insufficiency (requiring home oxygen therapy)
• Renal failure (serum creatinine > 2.0 mg/dL)
• Claustrophobic fear
• Unable to read and thus unable to complete the cognitive testing
• Pregnant women
• Patients who score < 24 on a baseline Mini Mental State Examination (MMSE) or ≥ 27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
• Patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI).
• Patients who have received chemotherapy in the last 12 months.
• Patients with COVID-19 diagnosis within the past 12 months

Where it is running

• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
• Duke University Health System — Durham, North Carolina, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Baylor Scott & White Research Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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