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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04305600
Other study ID # BRAIN-ICU-2
Secondary ID R01AG058639
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 31, 2027

Study information

Verified date March 2024
Source Vanderbilt University Medical Center
Contact Rebecca Abel, MA
Phone 615-875-3763
Email rebecca.abel@vumc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This BRAIN-ICU-2 study [Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study] is in direct response to PAR-17-038 and will determine ICU patients' main paths to decline, maintenance, or recovery of brain function. We will answer gaps in knowledge about long-term outcome of post-ICU brain disease by following the remaining ICU survivors from the original BRAIN-ICU-1 study with complete cognitive testing for the first time ever to 12 years (AIM 1). We will consent and enroll 567 new ICU patients at Vanderbilt and Rush Universities (i.e., BRAIN-ICU-2 cohort) and determine how detailed neuroimaging and cerebrospinal fluid samples can help reveal locations and mechanisms of injury beyond what we learned from the clinical information collected in our original study (AIM 2). Importantly, we are mirroring the existing world-renowned Rush Alzheimer's Disease Research Center brain bank program so that all patients enrolled in Aims 1 and 2 will able to donate their brains to science for the first-ever in-depth pathological study of those who do and do not get post-ICU dementia to define this disease formally (AIM 3)


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants whose brains show dementia-type changes in brain structure. Up to 312 weeks
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