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NCT04305600 · ClinicalTrials.gov registry record

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

A clinical trial of Critical Illness and Intensive Care Unit Delirium, sponsored by Vanderbilt University Medical Center.

Active
Registry status
567
Enrollment target
2
Study locations

NCT04305600 is a study of Critical Illness and Intensive Care Unit Delirium that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 567 participants, below the 3,132-participant average among 91 other Critical Illness trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04305600, a study of Critical Illness and Intensive Care Unit Delirium, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
567 participants
Enrollment target
2
Study locations

Study 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)

Study Locations (2)

Illinois

  • Rush University Medical Center - Chicago

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 567 participants
Start Date 2020-10-01
Est. Completion 2029-01-31

What the Registry Record Tells You About NCT04305600

The ClinicalTrials.gov registry entry for NCT04305600 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 567 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,132-participant average among 91 other Critical Illness trials with a reported enrollment target (82% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Critical Illness appearing as the primary indexed condition, and to 0 interventions.

NCT04305600 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Tennessee.

Frequently Asked Questions

What is clinical trial NCT04305600 about?

NCT04305600 is a clinical study titled "Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors, 2nd Study". 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 ...

What is the current status of trial NCT04305600?

This trial is currently active not recruiting. The enrollment target is 567 participants. The study started on 2020-10-01. Estimated completion is 2029-01-31.

What conditions does trial NCT04305600 study?

This clinical trial studies the following conditions: Critical Illness, Intensive Care Unit Delirium.

Who is sponsoring clinical trial NCT04305600?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04305600 being conducted?

This trial has 2 study locations across Illinois, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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