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NCT02834065 | COMPLETED | Cognition Disorders

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest
Sponsor:

Duke University

Brief Summary:

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.

Condition or disease

Cognition Disorders

Intervention/treatment

Cardiopulmonary bypass machine

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 273 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest
Actual Study Start Date : 2016-07-28
Estimated Primary Completion Date : 2022-01
Estimated Study Completion Date : 2023-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

Location Details

NCT02834065

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How to Participate

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Locations

Not yet recruiting

United States, Georgia

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Not yet recruiting

United States, North Carolina

Duke University Health System

Durham, North Carolina, United States, 27710

Not yet recruiting

United States, Pennsylvania

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Not yet recruiting

United States, Texas

Baylor Scott & White Research Institute

Plano, Texas, United States, 75093