Postoperative Delirium: Brain Vulnerability and Recovery
NCT ID: NCT03110185
Last Updated: 2020-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2015-11-25
2019-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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delirium
Patients in the cardiothoracic ICU diagnosed with postoperative delirium. Subjects will wear a diffuse optical tomography device in addition to the normal monitors. A non-contrast functional MRI will be performed.
EEG
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcDOT
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcMRI
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
no delirium
Patients in the cardiothoracic ICU not diagnosed with postoperative delirium. Subjects will be monitored in the same way as the delirium arm
EEG
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcDOT
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcMRI
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Interventions
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EEG
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcDOT
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
fcMRI
Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Surgery requiring cardiopulmonary bypass (CPB) for coronary artery bypass grafting, septal myectomy and/or heart valve repair/replacement
3. English speaking.
Exclusion Criteria
2. Automatic internal cardiac defibrillator or other implant for which non-contrast magnetic resonance imaging (MRI) is contraindicated
3. Concomitant aortic or cerebrovascular procedure
4. Inability to lay flat or still for MRI
5. Legal blindness or severe deafness
6. Seizure history
7. Known focal brain lesion larger than 3 cm.
Delirium Case Arm:
1\. Delirious as diagnosed by the Confusion Assessment Method (CAM)/ Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at some point during postoperative day 1-5.
Postoperative Control Arm:
1\. Not delirious as diagnosed by the CAM/CAM-ICU on postoperative day 1-5.
60 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Ben Palanca
Assistant Professor
Principal Investigators
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Ben Palanca, MD, PhD, MSc
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Barnes-Jewish Hospital/Washington University in St. Louis School of Medicine
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201511004
Identifier Type: -
Identifier Source: org_study_id
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