BRAIN-ICU-2 Study: Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction (Dementia) in ICU Survivors, 2nd Study

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ \*Adult patients in a medical and/or surgical ICU for the treatment of:

• shock (e.g., with vasopressors,

• intra-aortic balloon pump,

• Extracorporeal Membrane Oxygenation therapy) and/or

• respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]

Locations
United States
Illinois
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Rebecca Abel, MA
rebecca.abel@vumc.org
615-875-3763
Backup
Holly Stevens, MS
holly.stevens@vumc.org
615-936-3395
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 567
Treatments
Aim 1
Aim 1 participants will be recruited from participants in the first BRAIN study at VUMC.
Aim 2
Aim 2 participants will be recruited from the ICU populations at both VUMC and RUMC.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov