Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400062
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2006-11-15
Brief Title:
MIND-ICU Study Delirium and Dementia in Veterans Surviving ICU Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
MIND-ICU Study Delirium and Dementia in Veterans Surviving ICU Care
Status:
COMPLETED
Status Verified Date:
2019-04
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:
None
Brief Summary:
This will be the first large cohort study to define the epidemiology of and identify modifiable risk factors for long-term CI and functional deficits of ICU survivors The investigators will measure the independent contribution of risk factors such as delirium and exposure to sedative and analgesic medications to the incidence of long-term CI controlling for established risk factors eg age pre-existing CI and apoE genotype Defining the contributions of these risk factors will make it possible to develop preventive andor treatment strategies to reduce the incidence severity andor duration of long-term CI and improve functional recovery of patients with acute critical illness
Detailed Description:
Advances in critical care have led to improved survival among those admitted to intensive care units ICUs However survival is lower among those who develop ICU delirium and the quality of life among survivors may be affected by post-ICU long-term cognitive impairment CI that lasts months to years Long-term CI has been studied predominantly following cardiopulmonary bypass In the much larger group of medical and general surgical ICU patients the extent of this problem and its relationship to health-related quality of life is poorly characterized Evidence from 6 pilot cohorts including the investigators totaling 300 patients suggests that an astonishing 30 to 80 of ICU survivors experience long-term CI functionally equivalent to mildmoderate dementia although it may not be progressive and thus will be referred to as long-term CI Interestingly this cognitive impairment arises independent of severity of illness and older patients appear particularly prone The investigators work and the work of others have shown that delirium is a major independent risk factor for impaired cognitive function at hospital discharge and increased mortality at 6 months While it is not clear whether delirium itself is injurious to the brain or is simply a marker of brain injury it is clear that the onset of delirium in the ICU should not be considered innocuous rather it may be a determinant of long-term CI and health-related quality of life Having spent the last 8 years studying delirium and drug exposure during acute phases of critical illness and long-term CI after hospitalization the investigators are thoroughly prepared to continue the next phases of investigation in VA Department of Veterans Affairs patients many of whom are older and disproportionately at risk for adverse outcomes following ICU care
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