Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-28

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Deep Hypothermia

Initiation of circulatory arrest using the cardiopulmonary bypass machine at temperature ≤20 degrees Celsius

Group Type ACTIVE_COMPARATOR

Cardiopulmonary bypass machine

Intervention Type DEVICE

Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest

Low Hypothermia

Initiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 20.1 - 24.0 degrees Celsius

Group Type ACTIVE_COMPARATOR

Cardiopulmonary bypass machine

Intervention Type DEVICE

Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest

Moderate Hypothermia

Initiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 24.1 - 28 degrees Celsius

Group Type ACTIVE_COMPARATOR

Cardiopulmonary bypass machine

Intervention Type DEVICE

Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest

Interventions

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Cardiopulmonary bypass machine

Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest

Intervention Type DEVICE

Eligibility Criteria

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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

* \< 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No