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Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

NCT02834065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2023-02-24

No results posted yet for this study

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.

Conditions

  • Cognition Disorders

Interventions

DEVICE

Cardiopulmonary bypass machine

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

Sponsors & Collaborators

  • Emory Healthcare

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Baylor Scott and White Health

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Joseph P Mathew, MD, MHSc, MBA · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-28
Primary Completion
2022-01-31
Completion
2023-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834065 on ClinicalTrials.gov