ICU Survivors' dementia risk under the microscope
NCT ID NCT04305600
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 567 ICU survivors to see how their brain function changes over up to 12 years. Researchers will use brain scans, spinal fluid tests, and brain donations to find out why some people develop dementia after critical illness. The goal is to learn the causes of post-ICU brain decline, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could reveal why some ICU survivors develop dementia and point to ways to prevent or treat it.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find clear causes or lead directly to new therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 567 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
ICU patients at Vanderbilt University Medical Center in Nashville, Tennessee and Rush University Medical Center in Chicago, Illinois.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
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