Using Ramelteon to Reduce Delirium in ICU Patients
Delirium Reduction With Ramelteon
This study is testing if a sleep medication called ramelteon can help prevent and treat delirium in patients in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 506 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centennial Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05069428 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of ramelteon, a medication approved for insomnia, in preventing and treating delirium in patients in the intensive care unit (ICU). The hypothesis is that ramelteon may help regulate the sleep-wake cycle, which could potentially decrease the incidence of delirium in ICU patients. Participants will receive either ramelteon or a placebo, and the study will assess the outcomes related to delirium occurrence. The research is significant as there are currently no proven therapies for delirium in this setting.
Who should consider this trial
Good fit: Ideal candidates include medical or surgical ICU patients who can take medication orally or via a nasogastric tube within 48 hours of admission.
Not a fit: Patients with a history of cirrhosis, active alcohol withdrawal, or acute neurological conditions will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for preventing and treating delirium in ICU patients.
How similar studies have performed: Some previous studies have suggested benefits of ramelteon for delirium prevention, but there is limited prospective research data assessing its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee
- Centennial Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Johnson, MD — Centennial Medical Center
- Study coordinator: Jennifer Johnson, MD
- Email: jennifer.johnson19@hcahealthcare.com
- Phone: 214 604-8665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.