NCT00392795 · ACTIVE NOT RECRUITING
The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors
This is an observational study, not a drug test. Researchers follow adults treated in intensive care for respiratory failure or shock. They want to learn whether delirium and exposure to sedatives and pain medicines raise the risk of lasting memory and thinking problems. No treatment is being given. No phase is listed.
Eligibility criteria
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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-02