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

NCT03098459 | Active Not Recruiting DMC

• 2 other identifiers: 171335R01GM120484
• Study Type: observational
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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)

  12 months

Study Arms (1)

Critically Ill Trauma Patients

Non-intervention observational prospective cohort study

Other: Non-interventional observational prospective cohort study

Interventions

Non-interventional observational prospective cohort study OTHER

Non-interventional observational prospective cohort study

Critically Ill Trauma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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
• 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).

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Links

• NIH RePORTER

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Alzheimer Disease; Wounds and Injuries; Multiple Trauma; Brain Injuries, Traumatic; Critical Illness; Brain Diseases; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Dementia; Hematoma, Subdural; Inflammation; Neuroinflammatory Diseases; Burns; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Brain Injuries; Trauma, Nervous System; Disease Attributes; Pathologic Processes; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Intracranial Hemorrhage, Traumatic; Hematoma

Study Officials

• Mayur B Patel, MD,MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 31, 2017
• Study Start: November 2, 2017
• Primary Completion: February 25, 2022
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)