Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest



Status:Recruiting
Conditions:Cognitive Studies, Hospital
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:40 - Any
Updated:2/9/2019
Start Date:July 2016
End Date:July 2021
Contact:Tiffany Bisanar, RN, BSN
Email:tiffany.bisanar@duke.edu
Phone:919-681-0866

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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.

Purpose of the Study: Determine the effect of deep vs low vs moderate hypothermia on
neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns
after surgical circulatory arrest.

Hypothesis: Deep hypothermia is superior to moderate hypothermia in reducing postoperative
cognitive decline and preserving brain functional connectivity and that low hypothermia is
non-inferior to deep hypothermia.

Design and Procedures: 273 informed and consenting 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 will be randomized
to deep (<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during circulatory
arrest. Cognitive testing using a standard battery will occur preoperatively (baseline), at 4
weeks, and at 1 year after surgery. Neuroimaging procedures before surgery, and at 4 weeks
and 1 year after surgery will consist of high-resolution anatomic, resting-state fMRI
(rs-fMRI) and magnetic resonance spectroscopy (MRS) sequences. To characterize leukocyte
activation, whole blood will be drawn at 5 time points: at baseline (prior to surgery),
before circulatory arrest, 10 minutes after reperfusion, 10 minutes after CPB, and 4 hours
after CPB.

Inclusion Criteria:

- 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

Exclusion Criteria:

- < 40 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).
We found this trial at
3
sites
Durham, North Carolina 27710
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Durham, NC
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Atlanta, Georgia 30342
Principal Investigator: Edward P Chen, MD
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Atlanta, GA
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Philadelphia, Pennsylvania
Principal Investigator: Wilson Y Szeto, MD
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Philadelphia, PA
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