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ACTIVE NOT RECRUITING

NCT00392795

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

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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 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.

Official title: The BRAIN ICU Study: Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

826

Start Date

2007-01

Completion Date

2026-12

Last Updated

2026-02-02

Healthy Volunteers

Conditions

Delirium Cognition Disorders Dementia

Inclusion Criteria: * 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 Criteria: 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)

Locations (2)

Saint Thomas Hospital

Nashville, Tennessee, United States

Vanderbilt University Medical Center