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Low Hypothermia for Cognitive Disorders

N/A

Waitlist Available

Led By Joseph P Mathew, MD, MHSc, MBA

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 1 year postoperatively

Awards & highlights

Study Summary

This trial is testing whether deep, low, or moderate hypothermia during aortic arch surgery has an effect on neurocognitive function, brain connectivity, and leukocyte SUMOylation patterns.

Eligible Conditions

Cognitive Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1 year postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 1 year postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1 year postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in short-term cognition as measured by continuous cognitive score

Secondary outcome measures

Change in Duke Activity Status Index score

Change in SF-36 score

Change in SUMO 2/3 levels

+8 more

Trial Design

3Treatment groups

Active Control

Group I: Low HypothermiaActive Control1 Intervention

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

Group II: Moderate HypothermiaActive Control1 Intervention

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

Group III: Deep HypothermiaActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Scott & WhiteUNKNOWN

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,213 Total Patients Enrolled

1 Trials studying Cognitive Disorders

107 Patients Enrolled for Cognitive Disorders

Emory HealthcareOTHER

5 Previous Clinical Trials

1,592 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many sites are providing access to this research endeavor?

"This study involves 6 different medical centres, including Penn Presbyterian Medical Center in Philadelphia, Pennsylvania; Baylor Scott & White Research Institute in Plano, Texas; and Emory Saint Joseph's Hospital in Atlanta, Georgia."

Answered by AI

Are there still opportunities for participants to join this research effort?

"According to the information displayed on clinicaltrials.gov, this research is no longer accepting applications from potential participants. The trial was first posted in July 2016 and underwent its latest update in May 2022. Although not recruiting anymore, there are 93 other trials still welcoming candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

2016. "Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02834065.