Delirium Reduction With Ramelteon

Phase 4

Recruiting

• Conditions: Delirium
• Interventions: Drug: Ramelteon 8mg

• Registration Number: NCT05069428
• Lead Sponsor: Centennial Medical Center

Brief 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.

Detailed Description

Melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. It is reported that melatonin secretion may be impaired in ICU patients, and there is some question whether this may be a contributing factor to delirium occurrence. Ramelteon is a melatonin agonist with three to six times increased affinity for MT1 and MT2 receptors versus melatonin. It is FDA approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. There is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. The goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in ICU patients.

Study Timeline

• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2023-03-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 506

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramelteon	Ramelteon 8mg	ramelteon 8 mg crushed tablet daily at 20:30
placebo	Ramelteon 8mg	placebo powder equivalent grams at 20:30

Primary Outcome Measures

Name	Time	Method
Days alive without delirium or coma in the ICU	14 days	joint modeling approach taking account recurrence and terminating events

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	14 days	LOS
Incidence of delirium, as defined by a positive CAM-ICU-7	14 days	Incidence
Mortality at 14 days from randomization or hospital discharge	14 days	Mortality
Mean daily Confusion Assessment Method -7 CAM-ICU-7 score	14 days	Mean CAM-ICU-7 score
Duration of delirium, defined as number of days CAM-ICU positive	14 days	Duration

Trial Locations

Locations (1)

Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States