RECRUITING

Delirium Reduction With Ramelteon

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Delirium Reduction With Ramelteon

Quick Facts

Study Start:2023-03-26
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05069428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medical or surgical ICU patient
  2. * Ability to take oral or nasogastric tube within 48 hours of admission to ICU
  3. * Expected ICU length of stay and life expectancy at least 48 hours
  4. * Patient or POA capable of signing informed consent within 48 hours of ICU admission
  1. * Past medical history includes cirrhosis
  2. * Active alcohol withdrawal
  3. * Patients taking fluvoxamine prior to admission
  4. * Self-reported hypersensitivity to ramelteon
  5. * Incarcerated patients
  6. * Pregnant patients
  7. * Patients with acute neurological conditions including brain abscess, head bleed, meningitis
  8. * Patients who are transferred from an outside hospital where they have resided for greater than 4 days
  9. * Non-English speaking patients
  10. * Hearing-impaired patients requiring sign language for communication
  11. * Visually-impaired patients

Contacts and Locations

Study Contact

Jennifer Johnson, MD
CONTACT
214 604-8665
jennifer.johnson19@hcahealthcare.com
Chelsea Mitchell, PharmD
CONTACT
615 342-4725
chelsea.mitchell@hcahealthcare.com

Principal Investigator

Jennifer Johnson, MD
PRINCIPAL_INVESTIGATOR
Centennial Medical Center

Study Locations (Sites)

Centennial Medical Center
Nashville, Tennessee, 37205
United States

Collaborators and Investigators

Sponsor: Centennial Medical Center

  • Jennifer Johnson, MD, PRINCIPAL_INVESTIGATOR, Centennial Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-26
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-03-26
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Delirium