Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05069428

Delirium Reduction With Ramelteon

Led by Centennial Medical Center · Updated on 2024-08-22

506

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Delirium Reduction With Ramelteon

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Medical or surgical ICU patient
  • Ability to take oral or nasogastric tube medication within 48 hours of ICU admission
  • Expected ICU length of stay and life expectancy of at least 48 hours
  • Patient or legally authorized representative capable of signing informed consent within 48 hours of ICU admission
Not Eligible

You will not qualify if you...

  • History of cirrhosis
  • Active alcohol withdrawal
  • Taking fluvoxamine before admission
  • Known allergy or hypersensitivity to ramelteon
  • Incarcerated individuals
  • Pregnancy
  • Acute neurological conditions such as brain abscess, head bleed, or meningitis
  • Transferred from another hospital where patient stayed more than 4 days
  • Non-English speaking patients
  • Hearing impairment requiring sign language
  • Visual impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centennial Medical Center

Nashville, Tennessee, United States, 37205

Actively Recruiting

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Research Team

J

Jennifer Johnson, MD

CONTACT

C

Chelsea Mitchell, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Delirium Reduction With Ramelteon | DecenTrialz