Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT03550495
Eligibility Criteria:
Inclusion criteria are:
1. Patients who are ≥18 years of age
2. Patients admitted to the surgical ICU for \>48 hours OR
3. Patients admitted to the ICU \<24 hours who have been in the hospital \>48 hours
OR
4. Patients who return to the ICU after being discharged from the ICU to the floor due a complication or need for higher acuity care.
5. Patients admitted to any surgical service who are receiving care in the 7 West surgical ICU, who are either medically or conservatively managed (non-surgical) or surgically managed as part of their care
Exclusion criteria are:
1. Patients in whom CAM-ICU cannot be performed (severe dementia, stroke or other neurological condition, encephalopathy, mental retardation, severe psychiatric disorder, vegetative state, severe traumatic brain injury, deaf/blind, etc.)
2. Patients who don't speak or understand English
3. Current alcohol or substance abuse
4. Patients who already have delirium within 24-48 hours of their ICU admission \[Defined as a positive CAM-ICU test, or based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ( DSM-V) diagnostic criteria:
* Disturbance in attention (ie, reduced ability to direct, focus, sustain, and shift attention) and awareness.
* Change in cognition (eg, memory deficit, disorientation, language disturbance, perceptual disturbance) that is not better accounted for by a preexisting, established, or evolving dementia.
* The disturbance develops over a short period (usually hours to days) and tends to fluctuate during the course of the day.
* There is evidence from the history, physical examination, or laboratory findings that the disturbance is caused by a direct physiologic consequence of a general medical condition, an intoxicating substance, medication use, or more than one cause.\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03550495
Study Brief:
Protocol Section:
NCT03550495