Delirium Clinical Trial
— DREAMOfficial title:
Delirium Reduction With Ramelteon
The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.
Status | Recruiting |
Enrollment | 506 |
Est. completion date | December 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Medical or surgical ICU patient - Ability to take oral or nasogastric tube within 48 hours of admission to ICU - Expected ICU length of stay and life expectancy at least 48 hours - Patient or POA capable of signing informed consent within 48 hours of ICU admission Exclusion Criteria: - Past medical history includes cirrhosis - Active alcohol withdrawal - Patients taking fluvoxamine prior to admission - Self-reported hypersensitivity to ramelteon - Incarcerated patients - Pregnant patients - Patients with acute neurological conditions including brain abscess, head bleed, meningitis - Patients who are transferred from an outside hospital where they have resided for greater than 4 days - Non-English speaking patients - Hearing-impaired patients requiring sign language for communication - Visually-impaired patients |
Country | Name | City | State |
---|---|---|---|
United States | Centennial Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Centennial Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days alive without delirium or coma in the ICU | joint modeling approach taking account recurrence and terminating events | 14 days | |
Secondary | Mean daily Confusion Assessment Method -7 CAM-ICU-7 score | Mean CAM-ICU-7 score | 14 days | |
Secondary | Incidence of delirium, as defined by a positive CAM-ICU-7 | Incidence | 14 days | |
Secondary | Mortality at 14 days from randomization or hospital discharge | Mortality | 14 days | |
Secondary | Duration of delirium, defined as number of days CAM-ICU positive | Duration | 14 days | |
Secondary | ICU length of stay | LOS | 14 days |
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