MedTrace Logo

Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors, 2nd Study

NCT04305600 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 567

Last updated 2026-03-19

No results posted yet for this study

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)

Conditions

  • Critical Illness
  • Intensive Care Unit Delirium

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • E. Wesley Ely, MD · VUMC

  • Mayur Patel, MD · VUMC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT04305600 on ClinicalTrials.gov