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

NCT03931070 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 1364075
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium- and coma-free days

  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).

  Until discharge or up to 30 days of hospitalization, whichever is sooner.

Secondary Outcomes (7)

• Delirium assessment score Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) in Ramelteon group compared to the placebo group.

  Until discharge or up to 30 days of hospitalization, whichever is sooner.

• 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.

  Until discharge or up to 30 days of hospitalization, whichever is sooner.

• Number of ICU and hospital days.

  Until discharge or up to 30 days of hospitalization, whichever is sooner.

• Hours of total sleep, nighttime sleep and number of awakenings in ramelteon group compared to the placebo group.

  During the entire ICU stay upon enrollment up to 30 days.

• Richards-Campbell Sleep Questionnaire (RCSQ) scores in ramelteon group compared to the placebo group.

  Until discharge or up to 30 days of hospitalization, whichever is sooner.

Study Arms (2)

Mechanically ventilated

EXPERIMENTAL

Participants who are on mechanical ventilator at the time of study enrollment.

Drug: Ramelteon; Drug: Placebo - Cap

Non mechanically ventilated

EXPERIMENTAL

Participants who are not on mechanical ventilator at the time of study enrollment.

Drug: Ramelteon; Drug: Placebo - Cap

Interventions

Ramelteon DRUG

Patients assigned to Ramelteon group will receive 8mg of Ramelteon every night throughout the hospitalization or up to 30 days, whichever is sooner.

Also known as: Rozerem

Mechanically ventilated; Non mechanically ventilated

Placebo - Cap DRUG

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.

Also known as: Placebo

Mechanically ventilated; Non mechanically ventilated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mitchell M Levy, MD, MCCM, FCCP

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: April 30, 2019
• Study Start: May 9, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 10, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)