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

Study acronym: BRAIN-ICU
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v20

  2. Minor

    Completion date: Dec 2025 to Dec 2026

    Study Statusv19

  3. Minor

    5 amendments

    5 re-verifications since 2019-10-17, no change to tracked fields

    v14-v18

  4. Notable

    Lead sponsor: Vanderbilt University to Vanderbilt University Medical Center

    Completion date: Dec 2021 to Dec 2025

    Study Status, Sponsor/Collaboratorsv13

  5. Minor

    Completion date: Dec 2016 to Dec 2021

    Study Identification, Study Status, Study Designv12

Show 10 earlier versions

  1. Minor

    Completion date: Jun 2015 to Dec 2016

    Study Statusv11

  2. Minor

    Completion date: Jun 2013 to Jun 2015

    Study Statusv10

  3. Minor

    Completion date: Jun 2012 to Jun 2013

    Study Statusv9

  4. Minor

    Primary completion date changed from estimate of Dec 2011 to Dec 2010

    Completion date: Dec 2011 to Jun 2012

    Study Identification, Study Status, Sponsor/Collaborators, Study Designv8

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Enrollment target: estimated 800 to confirmed 826; Site details revised at 2 of 2 sites

    Study Identification, Study Status, Study Design, Contacts/Locationsv7

  6. Minor

    Eligibility criteria shortened, about 10 words

    Study title expanded, about 3 words

    Show what changed: Eligibility criteria
    [...] ill be excluded if they meet any of the following criteria: (1)Cumulative ICU time >5 days in the past 30 days, not includi [...] reate a state of flux regarding patients' cognitive baseline (3) Severe cognitive or neurodegenerative diseases that prevent [...] ease, severe Alzheimer's disease or dementia of any etiology (4) ICU admission post cardiopulmonary resuscitation with suspected anoxic injury (5) An active substance abuse or psychotic disorder, or a recen [...] it is particularly challenging to maintain long-term contact (6) Blind, deaf, or unable to speak English, as these condition [...] our ability to perf [...]
    Show what changed: Study title
    The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors

    Study Identification, Study Status, Eligibilityv6

  7. Minor

    Study sites: 3 to 2

    Primary completion date: Dec 2011; Completion date: Dec 2010 to Dec 2011; Eligibility criteria expanded, about 160 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: Adults Patients will be included if they are adult, patients in a medical and/or surgical ICU receiving treatment for any of the following: respiratory failure or generalcardiogenic surgicalor ICUs,septic on mechanical ventilation for < 72 hoursshock. Exclusion Criteria: Patients who meet the inclusion criteria will be excluded if they meet any of the following criteria: (1)Cumulative ICU admissiontime within 2 months that included over 3>5 days ofin ventilationthe past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cog [...] [...]

    Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locationsv5

  8. Minor

    Study title shortened, about 3 words

    Show what changed: Study title
    The BrainBRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors

    Study Identification, Study Status, Study Design, Eligibilityv4

  9. Minor

    Eligibility criteria expanded, about 2 words

    Study description expanded, about 1 word; Study title expanded, about 3 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: adultAdults, in medical or general surgical ICUs, on mechanical ventilation for < 72 hours Exclusion Criteria [...] reate a state of flux regarding patients' cognitive baseline, immediateImmediate extubation planned, severeSevere cognitive or neurodegenerative diseases that prevent a pati [...] ase, Alzheimer's disease, or severe dementia of any etiology, ICU admission post cardiopulmonary resuscitation with suspected anoxic injury, anAn active substance abuse or psychotic disorder, an exclusion [...] it is particularly challenging to maintain long-term contact, blindBlind, deaf, or unable to [...] [...]
    Show what changed: Study description
    [...] HRQL, controlling for other covariates such as age, medical vs.versus surgical ICU admission, pre-existing cognitive impairment, sepsis, and apoE genotype. This will pave the way for the development of preventive and/or treatment strategies to re [...]
    Show what changed: Study title
    The Brain Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors

    Study Identification, Study Status, Study Description, Conditions, Study Design, Eligibilityv3

  10. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Site details revised at 3 of 3 sites; Study title expanded, about 6 words

    Show what changed: Study title
    The BRAINBrain ICU Study: Bringing to Light the Risk Factors

    Study Identification, Study Status, Oversight, Conditions, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Delirium, Cognition Disorders, Dementia
Enrollment 826 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov