NCT04305600 · ACTIVE NOT RECRUITING

Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors, 2nd Study

This study is tracking ICU survivors over time to understand why some people develop lasting cognitive problems after critical illness. Researchers are collecting brain scans, spinal fluid, and long-term cognitive test results — and eventually brain tissue donations — to map out exactly what goes wrong in the brain after a serious ICU stay. This is an observational study, not a drug trial, so there is no treatment being tested.

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)

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 2026-03-19

View full record on ClinicalTrials.gov

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