DeliriumINSIGHT-ICUNCT03098459
Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
An observational study of Delirium and Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Cognitive Impairment, Alzheimer; Early Onset
- What is being tested?
- Non-interventional observational prospective cohort study
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read the 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 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.
- Conditions
- Delirium, Cognitive Impairment, Alzheimer; Early Onset, Trauma, Polytrauma, Traumatic Brain Injury
- Being tested
- Non-interventional observational prospective cohort study
- 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
- Medical subject headings
- Delirium, Cognitive Dysfunction, Alzheimer Disease, Wounds and Injuries, Multiple Trauma, Brain Injuries, Traumatic, Critical Illness, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional observational prospective cohort studyOther
Non-interventional observational prospective cohort study
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Trauma Patients | Non-intervention observational prospective cohort study Receives: Other: Non-interventional observational prospective cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start2 Nov 2017
- Primary completion25 Feb 2022
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Mayur Patel, Vanderbilt University Medical Center
- Investigators
- Mayur B Patel, MD,MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098459
- Sponsor's protocol ID
- 171335
- Other IDs
- R01GM120484
- Acronym
- INSIGHT-ICU
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2017
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study
- ClinicalTrials.gov ID
- NCT03098459
- Acronym / sponsor ID
- INSIGHT-ICU / 171335
- Conditions
- Delirium, Cognitive Impairment, Alzheimer; Early Onset, Trauma, Polytrauma, Traumatic Brain Injury
- Keywords
- Delirium, Cognitive Impairment, Alzheimer's Disease, Encephalopathy, Trauma, Polytrauma, ICU, Critical Illness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Trauma Patients | – | Other: Non-interventional observational prospective cohort studyNon-intervention observational prospective cohort study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- Inability to obtain informed consent within the 72 hours following injury
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional observational prospective cohort studyNon-interventional observational prospective cohort study | Other | Critically Ill Trauma Patients |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- NIH RePORTERLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayur B Patel, MD,MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LTCI (Long-term Cognitive Impairment) as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.