NCT03098459 · ACTIVE NOT RECRUITING
Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
This is an observational study — no drug or treatment is being tested. Researchers are tracking cognitive function over time in adults who were hospitalized in a trauma ICU for serious injuries. The goal is to understand how often long-term cognitive problems develop after traumatic injury, and what inflammation in the body might have to do with it. There is no phase, because no intervention is being tried.
Eligibility criteria
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: * 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-13