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

NCT04305600 | Active Not Recruiting

• 2 other identifiers: BRAIN-ICU-2R01AG058639
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 2

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 determine ICU patients' main paths to decline, maintenance, or recovery of brain function. We will answer gaps in knowledge about long-term outcome of post-ICU brain disease by following the remaining ICU survivors from the original BRAIN-ICU-1 study with complete cognitive testing for the first time ever to 12 years (AIM 1). We will consent and enroll 567 new ICU patients at Vanderbilt and Rush Universities (i.e., BRAIN-ICU-2 cohort) and determine how detailed neuroimaging and cerebrospinal fluid samples can help reveal locations and mechanisms of injury beyond what we learned from the clinical information collected in our original study (AIM 2). Importantly, we are mirroring the existing world-renowned Rush Alzheimer's Disease Research Center brain bank program so that all patients enrolled in Aims 1 and 2 will able to donate their brains to science for the first-ever in-depth pathological study of those who do and do not get post-ICU dementia to define this disease formally (AIM 3)

Conditions

Critical Illness; Intensive Care Unit Delirium

Keywords

critical illness; brain dysfunction; ICU delirium

Outcome Measures

Primary Outcomes (1)

• Number of participants whose brains show dementia-type changes in brain structure.

  Up to 312 weeks

Study Arms (2)

Aim 1

Aim 1 participants will be recruited from participants in the first BRAIN study at VUMC.

Aim 2

Aim 2 participants will be recruited from the ICU populations at both VUMC and RUMC.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients at Vanderbilt University Medical Center in Nashville, Tennessee and Rush University Medical Center in Chicago, Illinois.

You may qualify if:

• \*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 \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

All biological specimens (eg, serum, plasma, and DNA samples), maintain for batched assay after trial completion, will be stored in a locked -80°C freezer and labeled with date and study ID# only, without any patient identifiers. These samples will be accessible only to designated co-investigators. Results of the specified laboratory tests will be maintained in a password-protected database to be accessed only by designated coinvestigators.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• E. Wesley Ely, MD

  VUMC

  PRINCIPAL INVESTIGATOR

• Mayur Patel, MD

  VUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 12, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (2)