NCT03098459Active, not recruiting
Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 432 (actual)
- First submitted
- 21 Mar 2017
- Start date
- 2 Nov 2017
- Primary completion date
- 25 Feb 2022
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT03098459
What you commit to
- Study type: Observational
- Participants enrolled: 432
- From 2 Nov 2017 to the primary completion date, 25 Feb 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
Other illness
- 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
Other
- 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.
- Inability to understand English or Spanish or bilateral deafness or bilateral vision loss
- Inability to co-enroll with other studies
- Prisoners
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.