Status:
RECRUITING
Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors, 2nd Study
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Critical Illness
Intensive Care Unit Delirium
Eligibility:
All Genders
18+ years
Brief Summary
This BRAIN-ICU-2 study \[Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study\] is in direct response to PAR-17-038 and will determ...
Detailed Description
Delirium affects 50-70% of patients in Intensive Care Units (ICUs) with respiratory failure or shock.1-8 ICU delirium predicts death,2,8 length of stay,3 cost,9 and acquisition of Alzheimer's Disease ...
Eligibility Criteria
Inclusion
- \*Adult patients in a medical and/or surgical ICU for the treatment of:
- shock (e.g., with vasopressors,
- intra-aortic balloon pump,
- Extracorporeal Membrane Oxygenation therapy) and/or
- respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]
Exclusion
- MRI incompatibility (e.g. known claustrophobia, permanent metal implants)
- Cumulative ICU time \> 5 days in the past 30 days, prior to this hospitalization
- Inability to start the informed consent process within the 72 hours following organ failure:
- Attending physician refusal
- Patient and/or surrogate refusal
- 72-hour period of eligibility was exceeded before the patient was screened
- Patient unable to consent and no surrogate available within the 72-hour period
- Residence \> 100 miles from study site and do not regularly visit the area.
- Patients who are homeless and have no secondary contact person available.
- Cardiac surgery within the current hospitalization
- Dementia or other chronic neurologic disease or disorder that either makes the patient incapable of living independently at baseline or results in an IQCODE \>3.8(completed by the patient or their qualified surrogate). (Examples include but are not limited to mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology, and debilitating cerebrovascular disease.)
- Acute or subacute neurologic deficit that is expected to make the patient incapable of living independently after hospital discharge due to cognitive deficits. (Examples include, but are not limited to stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, and cerebral edema.)
- Inability to understand English or Spanish or bilateral deafness or bilateral vision loss
- Current enrollment in a study that does not allow co-enrollment
- Prisoners
- Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder) or recent (within the past 2 years) serious suicidal gesture necessitating hospitalization.
- Expected death within 12 hours of enrollment or lack of commitment to treatment by family or the medical team (e.g., likely to withdraw life support measures within 12 hours of enrollment)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
567 Patients enrolled
Trial Details
Trial ID
NCT04305600
Start Date
October 1 2020
End Date
January 31 2027
Last Update
March 7 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203