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The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU

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ClinicalTrials.gov Identifier: NCT03931070
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
Delirium is a disturbance in attention and awareness that occurs over a short period of time. Delirium is common in critically ill patients, and poor sleep quality in the intensive care unit (ICU) often worsens delirium. We aim to lower delirium in the intensive care unit (ICU) by using ramelteon, which is a drug used to improve sleep at night.

Condition or disease Intervention/treatment Phase
Delirium Drug: Ramelteon Drug: Placebo - Cap Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Ramelteon

Arm Intervention/treatment
Experimental: Ramelteon
Patients assigned to Ramelteon group will receive 8mg of Ramelteon every night throughout the hospitalization or up to 30 days, whichever is sooner.
Drug: Ramelteon
Nightly administration of Ramelteon 8 mg
Other Name: Rozerem

Placebo Comparator: Placebo
Patients assigned to Placebo group will receive placebo pill that is indistinguishable from Ramelteon, every night throughout the hospitalization or up to 30 days, whichever is sooner.
Drug: Placebo - Cap
Nightly administration of Placebo capsule, which is indistinguishable from Ramelteon
Other Name: Placebo




Primary Outcome Measures :
  1. Delirium- and coma-free days [ Time Frame: Until discharge or up to 30 days of hospitalization, whichever is sooner. ]
    The average number of delirium- and coma-free days as defined by Richmond Agitation-Sedation Scale (RASS) greater than -4 (RASS score is a range from -5 to +4, the lower score indicates comatose state, the higher score indicates more awakeness/agitation) and Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score greater than 3 (CAM-ICU-7 score ranges from 0 to 7, the higher score indicates more severe delirium).


Secondary Outcome Measures :
  1. Delirium assessment score (CAM-ICU-7) in Ramelteon group compared to the placebo group. [ Time Frame: Until discharge or up to 30 days of hospitalization, whichever is sooner. ]
    Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score will be measured to assess delirium. Score ranges from 0 to 7, and higher score indicates more severe delirium.

  2. Change in the delirium assessment scores (CAM-ICU-7) from baseline score on day one of enrolment in ramelteon group compared to the placebo group. [ Time Frame: Until discharge or up to 30 days of hospitalization, whichever is sooner. ]
    Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score will be measured to assess delirium. Score ranges from 0 to 7, and higher score indicates more severe delirium.

  3. Number of ICU and hospital days. [ Time Frame: Until discharge or up to 30 days of hospitalization, whichever is sooner. ]
    The average length of stay in the ICU and hospital, in days.

  4. Hours of total sleep, nighttime sleep and number of awakenings in ramelteon group compared to the placebo group. [ Time Frame: During the entire ICU stay upon enrollment up to 30 days. ]
    The average number of hours of sleep, and the number of awakenings as measured by actigraphy, which is a wearable accelerometer that is validated to assess sleep quality.

  5. Richards-Campbell Sleep Questionnaire (RCSQ) scores in ramelteon group compared to the placebo group. [ Time Frame: Until discharge or up to 30 days of hospitalization, whichever is sooner. ]
    RCSQ is a validated sleep survey using visual analog scale (VAS) filled out by the subject, which comprises of 5 questions with scores ranging from 0-100, and higher score indicates worse sleep quality.

  6. Telephone Interview for Cognitive Status (TICS) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group. [ Time Frame: At one, three, and six month post ICU discharge. ]
    TICS is a validated phone-based assessment of cognitive status. The score ranges from 0 to 40, lower score indicates worse degree of cognitive impairment.

  7. EQ-5D (EuroQol-5Dimensions) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group. [ Time Frame: At one, three, and six month post ICU discharge. ]
    EQ-5D is a health related quality of life questionnaire that is telephone-based. It is comprised of 5 health related quality of life questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and each question is in multiple-choice format. The score ranges from 5 to 25, with the higher scores indicating worse health-related quality of life assessment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 years of age newly admitted to ICU and expected to stay in ICU for at least three days as determined by study personnel.
  • Able to take medicine via enteral access.

Exclusion Criteria:

  • Taking ramelteon or fluvoxamine
  • Expected life expectancy of less than 48 hours.
  • Pre-existing dementia
  • Alcohol withdrawal admission diagnosis
  • Acute neurological condition (brain abscess/tumor, head bleed, stroke, seizure)
  • Known allergy/intolerance to ramelteon
  • Severe liver dysfunction: Hepatic encephalopathy, cirrhosis (Child-Pugh class C or greater)
  • Suicide attempt, admission for acute psychiatric illness
  • GI bleed or other inability to use enteral nutrition
  • Pregnant patient
  • Incarcerated
  • Prior enrollment into the study
  • On paralytics at the time of admission
  • Unable to get enteral feeds/meds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931070


Contacts
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Contact: Jisoo Lee, MD 2244307695 jisooleemd@gmail.com
Contact: Debasree Banerjee, MD, MSc banerjed19@gmail.com

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jisoo Lee, MD    2244307695    jisooleemd@gmail.com   
Contact: Mitchell M Levy, MD,MCCM,FCCP    4014442776    mitchell_levy@brown.edu   
Principal Investigator: Mitchell M Levy, MD, MCCM, FCCP         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Mitchell M Levy, MD, MCCM, FCCP Brown University
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03931070    
Other Study ID Numbers: 1364075
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders