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

Running, not enrolling

Conditions studied: Delirium, Cognitive Impairment, Alzheimer; Early Onset, Trauma, Polytrauma, Traumatic Brain Injury, ICU, Critical Illness

In brief

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.

Key facts

Study ID

NCT03098459

Run by

Vanderbilt University Medical Center

People needed

432

Starts

2017-11-02

Expected to finish

2027-10-01

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.