MIND-ICU Study: Delirium and Dementia in Veterans Surviving ICU Care

Completed

Conditions studied: Delirium, Aging, Dementia

In brief

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 (e.g., age, pre-existing CI, and apoE genotype). Defining the contributions of these risk factors will make it possible to develop preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term CI and improve functional recovery of patients with acute critical illness.

Key facts

Study ID

NCT00400062

Run by

VA Office of Research and Development

People needed

800

Starts

2007-07-01

Expected to finish

2017-12-01

Last updated by the study team

2019-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be included if they are adult patients in a medical and/or surgical ICU receiving treatment for any of the following: respiratory failure or cardiogenic or septic shock.

You may not qualify if…

• Patients who meet the inclusion criteria will be excluded if they meet any of the following criteria:
• Cumulative ICU time > 5 days in the past 30 days, not including the current ICU stay, as this might create a state of flux regarding patients' cognitive baseline.
• Severe cognitive or neurodegenerative diseases that prevent a patient from living independently at baseline, including mental illness requiring institutionalization, acquired or congenital mental retardation, known brain lesions, traumatic brain injury, cerebrovascular accidents with resultant moderate to severe cognitive deficits or ADL dependency, Parkinson's disease, Huntington's disease, severe Alzheimer's disease or dementia of any etiology.
• ICU admission post cardiopulmonary resuscitation with suspected anoxic injury
• An active substance abuse or psychotic disorder, or a recent (within the past 6 months) serious suicidal gesture necessitating hospitalization. This exclusion that will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact.
• Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the follow-up evaluation interviews.
• Overly moribund and not expected to survive for an additional 24 hours and/or withdrawing life support to focus on comfort measures only.
• Prisoners.
• Patients who live further than 200 miles from the study site and who do not regularly visit the study site area.
• The onset of the current episode of respiratory failure, cardiogenic shock, or septic shock was >72 hours ago.
• Patients who have had cardiac bypass surgery within the past 3 months (including the current hospitalization).
• Patients who are homeless and have no secondary contact person available. This exclusion will enrich follow-up rates by avoiding patients with whom it is particularly challenging to maintain long-term contact.

Where it is running

• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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