Understanding brain dysfunction in ICU survivors

BRAIN-ICU-2 Study: Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction (Dementia) in ICU Survivors, 2nd Study

This study is trying to see how being in the ICU affects the brain and thinking skills of patients who survived critical illness, to better understand long-term effects like memory problems and their link to Alzheimer's disease.

Quick facts

• Study type: Observational
• Enrollment: 567 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT04305600 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the risk factors and incidence of neuropsychological dysfunction in patients who have survived critical illness and intensive care unit (ICU) treatment. By following ICU survivors from a previous study, researchers will conduct comprehensive cognitive testing and analyze neuroimaging and cerebrospinal fluid samples to uncover the mechanisms of brain injury. The study will enroll 567 new ICU patients at Vanderbilt and Rush Universities to enhance understanding of long-term outcomes related to ICU delirium and its connection to Alzheimer's disease and related dementias.

Who should consider this trial

Good fit: Ideal candidates include adult patients currently receiving treatment in a medical or surgical ICU for shock or respiratory failure.

Not a fit: Patients with prior significant ICU stays or those unable to consent within the required timeframe may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing and treating cognitive decline in ICU survivors.

How similar studies have performed: Previous studies have indicated a significant incidence of cognitive decline in ICU survivors, suggesting that this approach could yield valuable insights.

Eligibility criteria

Inclusion Criteria:

\*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 Criteria:

1. MRI incompatibility (e.g. known claustrophobia, permanent metal implants)
2. Cumulative ICU time \> 5 days in the past 30 days, prior to this hospitalization
3. 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
4. Residence \> 100 miles from study site and do not regularly visit the area.
5. Patients who are homeless and have no secondary contact person available.
6. Cardiac surgery within the current hospitalization
7. 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.)
8. 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.)
9. Inability to understand English or Spanish or bilateral deafness or bilateral vision loss
10. Current enrollment in a study that does not allow co-enrollment
11. Prisoners
12. 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.
13. 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)

Where this trial is running

Chicago, Illinois and 1 other locations

• Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: E. Wesley Ely, MD — Vumc
• Study coordinator: Rebecca Abel, MA

Conditions Critical Illness; Intensive Care Unit Delirium; critical illness; brain dysfunction; ICU delirium