Delirium Reduction With Ramelteon

Delirium Clinical Trial

— DREAM  

Official title:

Delirium Reduction With Ramelteon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069428
• Other study ID #: 2021-438
• Status: Recruiting
• Phase: Phase 4
• Start date: March 26, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Centennial Medical Center
• Contact: Jennifer Johnson, MD
• Phone: 214 604-8665
• Email: jennifer.johnson19[@]hcahealthcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Ramelteon 8mg
administered crushed, orally at 20:30

Locations

Country	Name	City	State
United States	Centennial Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Centennial Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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