The BRAIN Intensive Care Unit (ICU) Study: Bringing to Light the Risk Factors (BRAIN-ICU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00392795|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2006
Last Update Posted : December 7, 2022
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|Condition or disease|
|Delirium Cognition Disorders Dementia|
|Study Type :||Observational|
|Actual Enrollment :||826 participants|
|Official Title:||The BRAIN ICU Study: Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2025|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392795
|United States, Tennessee|
|Saint Thomas Hospital|
|Nashville, Tennessee, United States, 37205|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||E Wesley Ely, MD, MPH||Vanderbilt University/VA TN Valley GRECC|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Wes Ely, Professor of Medicine, Vanderbilt University Medical Center|
|Other Study ID Numbers:||
R01AG027472 ( U.S. NIH Grant/Contract )
|First Posted:||October 26, 2006 Key Record Dates|
|Last Update Posted:||December 7, 2022|
|Last Verified:||December 2022|
Long-term cognitive impairment
sedatives and analgesics
Central Nervous System Diseases
Nervous System Diseases