Delirium Reduction With Ramelteon
- Conditions
- Delirium
- Registration Number
- NCT05069428
- Lead Sponsor
- Centennial Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 506
Inclusion Criteria:<br><br> - Medical or surgical ICU patient<br><br> - Ability to take oral or nasogastric tube within 48 hours of admission to ICU<br><br> - Expected ICU length of stay and life expectancy at least 48 hours<br><br> - Patient or POA capable of signing informed consent within 48 hours of ICU admission<br><br>Exclusion Criteria:<br><br> - Past medical history includes cirrhosis<br><br> - Active alcohol withdrawal<br><br> - Patients taking fluvoxamine prior to admission<br><br> - Self-reported hypersensitivity to ramelteon<br><br> - Incarcerated patients<br><br> - Pregnant patients<br><br> - Patients with acute neurological conditions including brain abscess, head bleed,<br> meningitis<br><br> - Patients who are transferred from an outside hospital where they have resided for<br> greater than 4 days<br><br> - Non-English speaking patients<br><br> - Hearing-impaired patients requiring sign language for communication<br><br> - Visually-impaired patients
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Days alive without delirium or coma in the ICU
- Secondary Outcome Measures
Name Time Method Mean daily Confusion Assessment Method -7 CAM-ICU-7 score;Incidence of delirium, as defined by a positive CAM-ICU-7;Mortality at 14 days from randomization or hospital discharge;Duration of delirium, defined as number of days CAM-ICU positive;ICU length of stay