The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors

Study acronym: BRAIN-ICU
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv20
  2. Study completion date: Dec 2025 to Dec 2026v19
  3. 5 versions Re-verified since Oct 17, 2019, no change to tracked fieldsv14-v18
  4. Lead sponsor: Vanderbilt University to Vanderbilt University Medical Center
    • Study completion date: Dec 2021 to Dec 2025
    v13
  5. Study completion date: Dec 2016 to Dec 2021v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study completion date: Jun 2015 to Dec 2016v11
  2. Study completion date: Jun 2013 to Jun 2015v10
  3. Study completion date: Jun 2012 to Jun 2013v9
  4. Primary completion date changed from estimate of Dec 2011 to Dec 2010
    • Study completion date: Dec 2011 to Jun 2012
    v8
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 800 to confirmed 826
    • Site details revised at 2 of 2 sites
    v7
  6. Eligibility criteria shortened, about 10 words
    • Study title expanded, about 3 words
    v6
  7. Study sites: 3 to 2
    • Primary completion date: Dec 2011
    • Study completion date: Dec 2010 to Dec 2011
    • Eligibility criteria expanded, about 160 words
    v5
  8. Study title shortened, about 3 wordsv4
  9. Eligibility criteria expanded, about 2 words
    • Study description expanded, about 1 word
    • Study title expanded, about 3 words
    v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    • Study title expanded, about 6 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and analgesic medications) in ICU patients. The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment, controlling for other established risk factors including age, pre-existing cognitive impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.
Trial Details
NCT Number NCT00392795
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Delirium, Cognition Disorders, Dementia
Related terms Cognition Disorders, Critical Illness, Delirium, Dementia
Enrollment 826 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov