RECRUITING

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

Conditions

Critical Illness Intensive Care Unit Delirium brain dysfunction ICU delirium

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2020-10-01

Study Completion:2027-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04305600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* shock (e.g., with vasopressors, * intra-aortic balloon pump, * Extracorporeal Membrane Oxygenation therapy) and/or * respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]	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)

Inclusion Criteria

Exclusion Criteria

* shock (e.g., with vasopressors,
* intra-aortic balloon pump,
* Extracorporeal Membrane Oxygenation therapy) and/or
* respiratory failure \[e.g., on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV)\]

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)

Contacts and Locations

Study Contact

Rebecca Abel, MA

CONTACT

615-875-3763

rebecca.abel@vumc.org

Holly Stevens, MS

CONTACT

615-936-3395

holly.stevens@vumc.org

Principal Investigator

E. Wesley Ely, MD

PRINCIPAL_INVESTIGATOR

VUMC

Mayur Patel, MD

PRINCIPAL_INVESTIGATOR

VUMC

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60612

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

E. Wesley Ely, MD, PRINCIPAL_INVESTIGATOR, VUMC
Mayur Patel, MD, PRINCIPAL_INVESTIGATOR, VUMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01

Study Completion Date2027-01-31

Study Record Updates

Study Start Date2020-10-01

Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

critical illness
brain dysfunction
ICU delirium

Additional Relevant MeSH Terms

Critical Illness
Intensive Care Unit Delirium