Status:
ACTIVE_NOT_RECRUITING
The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Delirium
Cognition Disorders
Eligibility:
All Genders
18+ years
Brief Summary
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 medi...
Detailed Description
Among Intensive Care Unit (ICU) survivors, subsequent cognitive and functional decline are the greatest threats to meaningful recovery. Six small cohorts indicate that an alarming 30% to 80% of the in...
Eligibility Criteria
Inclusion
- 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 cardiogenic or septic shock.
Exclusion
- Patients who meet the inclusion criteria will be excluded if they meet any of the following criteria:
- Cumulative ICU time \>5 days in the past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cognitive baseline
- Severe cognitive or neurodegenerative diseases that prevent a patient from living independently at baseline, including mental illness requiring institutionalization, acquired or congenital mental retardation, known brain lesions, traumatic brain injury, cerebrovascular accidents with resultant moderate to severe cognitive deficits or ADL dependency, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology
- ICU admission post cardiopulmonary resuscitation with suspected anoxic injury
- An active substance abuse or psychotic disorder, or a recent (within the past 6 months) serious suicidal gesture necessitating hospitalization. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
- Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the follow-up evaluation interviews.
- Overly moribund and not expected to survive for an additional 24 hours and / or withdrawing life support to focus on comfort measures only.
- Prisoners.
- Patients who live further than 200 miles from Nashville and who do not regularly visit the Nashville area.
- Patients who are homeless and have no secondary contact person available. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact
- The onset of the current episode of respiratory failure, cardiogenic shock, or septic shock was \> 72 hours ago.
- Patients who have had cardiac bypass surgery within the past 3 months (including the current hospitalization)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
826 Patients enrolled
Trial Details
Trial ID
NCT00392795
Start Date
January 1 2007
End Date
December 1 2026
Last Update
January 15 2025
Active Locations (2)
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1
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232