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Delirium Reduction With Ramelteon (DREAM)

Primary Purpose

Delirium

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ramelteon 8mg
Sponsored by
Centennial Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centennial Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ramelteon

placebo

Arm Description

ramelteon 8 mg crushed tablet daily at 20:30

placebo powder equivalent grams at 20:30

Outcomes

Primary Outcome Measures

Days alive without delirium or coma in the ICU
joint modeling approach taking account recurrence and terminating events

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2021
Last Updated
March 26, 2023
Sponsor
Centennial Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05069428
Brief Title
Delirium Reduction With Ramelteon
Acronym
DREAM
Official Title
Delirium Reduction With Ramelteon
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centennial Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blinded, placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ramelteon
Arm Type
Experimental
Arm Description
ramelteon 8 mg crushed tablet daily at 20:30
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo powder equivalent grams at 20:30
Intervention Type
Drug
Intervention Name(s)
Ramelteon 8mg
Intervention Description
administered crushed, orally at 20:30
Primary Outcome Measure Information:
Title
Days alive without delirium or coma in the ICU
Description
joint modeling approach taking account recurrence and terminating events
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Mean daily Confusion Assessment Method -7 CAM-ICU-7 score
Description
Mean CAM-ICU-7 score
Time Frame
14 days
Title
Incidence of delirium, as defined by a positive CAM-ICU-7
Description
Incidence
Time Frame
14 days
Title
Mortality at 14 days from randomization or hospital discharge
Description
Mortality
Time Frame
14 days
Title
Duration of delirium, defined as number of days CAM-ICU positive
Description
Duration
Time Frame
14 days
Title
ICU length of stay
Description
LOS
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Johnson, MD
Phone
214 604-8665
Email
jennifer.johnson19@hcahealthcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsea Mitchell, PharmD
Phone
615 342-4725
Email
chelsea.mitchell@hcahealthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Johnson, MD
Organizational Affiliation
Centennial Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Johnson, MD
Phone
214-604-8665
Email
jennifer.johnson19@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Chelsea Mitchell, ParmD
Phone
6153424725
Email
chelsea.mitchell@hcahealthcare.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Delirium Reduction With Ramelteon

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