Delirium Reduction With Ramelteon

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centennial Medical Center

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