NCT04305600: BRAIN-2

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

Active, enrolled Last updated 19 March 2026

What this trial tests

trial in Critical Illness in 567 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2020

Primary endpoint
31 January 2028

31 January 2029

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	567
Start date	1 October 2020
Primary completion	31 January 2028
Estimated completion	31 January 2029
Sites	2 locations across United States

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Intensive Care Unit Delirium — all drugs for Intensive Care Unit Delirium →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Critical Illness or Intensive Care Unit Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nutritional Risk at intensive care unit admission and outcomes in survivors of critical illness.
   Mart MF, Girard TD, Thompson JL, Whitten-Vile H, et al · · 2021 · cited 11× · PMID 34130034 · DOI 10.1016/j.clnu.2021.05.005