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

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ClinicalTrials.gov Identifier: NCT03098459
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mayur Patel, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Delirium Cognitive Impairment Alzheimer; Early Onset Trauma Polytrauma Traumatic Brain Injury ICU Critical Illness Other: Non-interventional observational prospective cohort study

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 900 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.


Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Critically Ill Trauma Patients
Non-intervention observational prospective cohort study
Other: Non-interventional observational prospective cohort study
Non-interventional observational prospective cohort study




Primary Outcome Measures :
  1. LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 12 months ]
    LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098459


Contacts
Contact: Mayur B Patel, MD,MPH 6153225000 mayur.b.patel@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Mayur B Patel, MD, MPH       mayur.b.patel@Vanderbilt.edu   
Principal Investigator: Mayur B Patel, MD, MPH         
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Mayur B Patel, MD,MPH Vanderbilt University Medical Center

Additional Information:
Responsible Party: Mayur Patel, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03098459     History of Changes
Other Study ID Numbers: 171335
R01GM120484 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mayur Patel, Vanderbilt University Medical Center:
Head Injury
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
Long-term Cognitive Impairment
ICU-related Dementia

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
Cognitive Dysfunction
Brain Injuries, Traumatic
Delirium
Critical Illness
Multiple Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes