Please select the eligibility criteria that correspond to the clinical trial below.
Title: The BRAIN ICU Study: Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors
Brief Summary: The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. 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 and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.


Options:
A: Inclusion Criteria:

* Patients staying on the ICU for at least 72 hours (with greater than 24 hours of artificial ventilation)

Exclusion Criteria:

* ICU stay \< 72 hours
* Too confused for informed consent
* Pre-existing psychotic illness
B: Inclusion Criteria:

* Age ≥ 18 years
* Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
* APACHE II score ≥ 12 ≤ 29
* Unrecognized dementia diagnosis

Exclusion Criteria:

* Delirium at randomization (Positive CAM-ICU score)
* Participation in scientific projects which include patient interviews
* Not Speak and understand Danish
C: Patient inclusion criteria:

* age \>=18 and
* mechanical ventilation for more than 48 consecutive hours

Patient exclusions (pre-consent):

* current significant cognitive impairment (\>=3 errors on the Callahan scale) or lacks decisional capacity
* pre-existing significant cognitive impairment
* residence at location other than home before hospital admission
* need for a translator because of poor English fluency \[many study instruments are not validated in other languages\]
* expected survival \<3 months
* discharged to hospice (outpatient or inpatient)
* not liberated from mechanical ventilation at discharge

Additional patient exclusion criteria (present post-consent but pre-randomization):

* Patients will become ineligible if they become too ill to participate
* they develop significant cognitive disability, exhibit suicidality, they do not return home within 2 months after hospital discharge, or die.

Informal caregiver inclusion criteria:

* age \>=18 years
* person most likely to provide the most post-discharge care.

Exclusions for caregivers are:

* history of significant cognitive impairment
* English fluency poor enough to require a medical translator

Informal caregiver exclusion criteria present after consent but before randomization:

* no longer available
* become too ill to participate
* exhibit suicidality

A total of 200 patient-caregiver dyads (total cohort = 400) are targeted
D: Inclusion Criteria:

* 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.

Exclusion Criteria:

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 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 Nashville and who do not regularly visit the Nashville area.
* 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
* 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)

Answer: D