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Active, not recruitingNCT03098459INSIGHT-ICUUpdated Jan 13, 2026

Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study

An observational study in Delirium, Cognitive Impairment and Alzheimer; Early Onset, sponsored by Vanderbilt University Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
432
Ages
18 Years and older
Sex
All
01

Study summary

Cognitive skills are essential to live independently, manage finances, maintain employment, and function in society. Loss of these cognitive skills puts a tremendous burden on society as seen with dementias, Alzheimer's disease, and traumatic brain injury. The INSIGHT-ICU Study (Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms Gleaned after Hospitalization in Trauma-ICU Study) is the first comprehensive and longitudinal long-term cognitive impairment study after traumatic injury. The societal impact of long-term cognitive impairment after trauma is immense given that these patients are young and constitute a large proportion of employable adults.

Read the detailed description

Cognitive skills are the crucial abilities required to manage money, maintain employment, and live independently. Long-term cognitive impairment (LTCI) is a disabling loss of these skills that can persist for months to years. LTCI frequently occurs after primary brain injury (e.g., traumatic brain injury, hypoxia), but older LTCI research has not characterized primary brain injury using NIH Common Data Elements in Imaging, the contributions of polytrauma, and the time-course of the critical illness, including secondary brain injury (i.e., delirium). In our recent large study of ICU patients without primary brain injury, over 50% of patients had LTCI and nearly 50% were newly unemployed at one-year post-discharge. In-hospital delirium was the major independent risk factor for LTCI. Surprisingly, this delirium-related LTCI was similar to the LTCI seen in past studies after moderate traumatic brain injury. Thus, both primary and secondary brain injury are associated with LTCI, yet they have not been studied together. There is an unmet need to define the independent risks of primary brain injury and delirium in LTCI. The trauma ICU patient is at combined risk for primary brain and/or multisystem injuries, secondary brain injury, and critical illness; these critically injured patients are the unique population to address this knowledge gap.

Therefore, our FIRST HYPOTHESIS is that delirium duration is an independent risk for the severity of LTCI, controlling for confounders of co-morbidities, socioeconomic status, pre-injury employment, primary brain injury, polytrauma, and critical illness. AIM 1 will address this hypothesis by defining the independent risks of primary and secondary brain injury on the severity of LTCI among trauma ICU subjects.

But, LTCI's real-world impact on employment has not been explained or adjusted for the above confounders and social factors. Accordingly, our SECOND HYPOTHESIS is that LTCI severity is an independent risk for lower level of employment, adjusting for similar confounders. AIM 2 will delineate the independent risk of LTCI severity on employment among trauma ICU survivors. Lastly, LTCI pathogenesis may be related to persistent inflammation.

So, our THIRD HYPOTHESIS is that hospital discharge biomarkers of persistent inflammation will be independent risks for LTCI severity, adjusting for similar confounders. AIM 3 will explore the mechanistic role of plasma inflammatory biomarkers on LTCI severity among trauma ICU survivors.

02

Conditions studied

  • Delirium
  • Cognitive Impairment
  • Alzheimer; Early Onset
  • Trauma
  • Polytrauma
  • Traumatic Brain Injury
  • ICU
  • Critical Illness

Keywords

  • Delirium
  • Cognitive Impairment
  • Alzheimer's Disease
  • Encephalopathy
  • Trauma
  • Polytrauma
  • ICU
  • Critical Illness
  • Traumatic Brain Injury
  • INSIGHT-ICU
  • INSIGHT
  • Intracerebral hemorrhage
  • Subarachnoid hemorrhage
  • Neurotrauma
  • Neuropsychology
  • Dementia
  • Critical Care
  • Subdural hemorrhage
  • Cognition
  • Neuropsychological Outcomes
  • Neuropsychology Dysfunction
  • Inflammation
  • Neuroinflammation
  • Inflammatory Mechanisms
  • Burn
  • Critically Injured
  • Injury
  • Head Injury
  • Long-term Cognitive Impairment
  • ICU-related Dementia
  • Employment
  • Return to Work
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be broadly eligible for inclusion if they are Adult trauma and/or burn patients, injury from any mechanism, requiring admission to an Adult ICU for the treatment of shock (any type), respiratory failure, and/or neurologic failure, including monitoring for deteriorating brain function.

Inclusion criteria

  • Adult trauma and/or burn patients, injury from any mechanism, requiring admission to an Adult ICU for the treatment of shock (any type), respiratory failure, and/or neurologic failure, including monitoring for deteriorating brain function.

Exclusion criteria

Exclusion Criteria:

  • Inability to obtain informed consent within the 72 hours following injury

    • 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
  • Residence > 200 miles from study site and do not regularly visit the Nashville area.
  • Patients who are homeless and have no secondary contact person available.
  • Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
  • Inability to understand English or Spanish or bilateral deafness or bilateral vision loss
  • Inability to co-enroll with other studies
  • Prisoners
  • Substance abuse requiring treatment, known psychotic disorder (e.g., schizophrenia or schizoaffective disorder), or recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
  • Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of screening).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
432 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Critically Ill Trauma Patients

    Non-intervention observational prospective cohort study

    Other: Non-interventional observational prospective cohort study

Interventions

  • OtherNon-interventional observational prospective cohort study

    Non-interventional observational prospective cohort study

05

What researchers measure

Primary outcomes

  1. LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 12 months

06

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
07

References and documents

Related links

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03098459
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
Responsible party
Mayur Patel (Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Mar 31, 2017
Start date
Nov 2, 2017
Primary completion
Feb 25, 2022
Completion
Oct 2027 (estimated)
Last update
Jan 13, 2026

Study contacts

Mayur B Patel, MD,MPH
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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