Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2006-10-25
Brief Title:
The BRAIN Intensive Care Unit ICU Study Bringing to Light the Risk Factors
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The BRAIN ICU Study Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAIN-ICU
Brief Summary:
The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment ie development of delirium and exposure to sedative and analgesic medications in ICU patients The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment controlling for other established risk factors including age pre-existing cognitive impairment and apolipoprotein E apoE genotype Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive andor treatment strategies to reduce the incidence severity andor duration of long-term cognitive impairment and improve functional recovery for patients with critical illness
Detailed Description:
Among Intensive Care Unit ICU survivors subsequent cognitive and functional decline are the greatest threats to meaningful recovery Six small cohorts indicate that an alarming 30 to 80 of the increasingly millions of ICU survivors develop an acquired long-term cognitive impairment LTCI functionally equivalent to mildmoderate dementia that may last years Additionally major deficits in health-related quality of life HRQL functional status and an ICU accelerated frailty are common especially in the elderly A leading and potentially modifiable risk factor for these devastating outcomes may be ICU delirium which is a predictor of higher mortality higher cost and poor cognitive function at discharge Additionally heavy and prolonged exposure to potent psychoactive medications routinely administered in high doses to ventilated patients may have lasting yet preventable cognitive and functional effects In this proposal Aims 1 and 3 will determine whether delirium is an independent risk factor for the incidence severity andor duration of LTCI Aim 1 and impaired HRQL Aim 3 in ICU survivors Likewise Aims 2 and 4 will determine whether degree of exposure to sedative and analgesic medications in ICU patients is an independent risk factor for the incidence severity andor duration of LTCI Aim 2 and impaired HRQL Aim 4 The study will be a prospective cohort study enrolling 800 mechanically ventilated medical and surgical patients from 3 diverse medical centers over a 39 month period with comprehensive follow-up testing at 3 and 12 months after hospital discharge This study will quantify whether delirium and sedativeanalgesic exposure are indeed risk factors for LTCI and HRQL controlling for other covariates such as age medical versus surgical ICU admission pre-existing cognitive impairment sepsis and apoE genotype This will pave the way for the development of preventive andor treatment strategies to reduce long-term cognitive impairment and improve the functional recovery of older and younger ICU patients for decades to come Major threats to recovery for ICU survivors are acquired cognitive and functional decline that can last years especially in older patients To pave the way for future preventive and interventional strategies the cohort will determine to what degree delirium and potent sedatives and analgesics are risk factors for long-term cognitive impairment and functional decline following critical illness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG027472 | NIH | None | httpsreporternihgovquickSearchR01AG027472 |