Delirium Reduction With Ramelteon
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ramelteon 8mg.
- Who it may be relevant to
- Registry conditions: Delirium. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Ramelteon 8mg
administered crushed, orally at 20:30
Primary outcome measures
- Days alive without delirium or coma in the ICU [Time frame: 14 days]
Secondary outcome measures (5)
- Mean daily Confusion Assessment Method -7 CAM-ICU-7 score [Time frame: 14 days]
- Incidence of delirium, as defined by a positive CAM-ICU-7 [Time frame: 14 days]
- Mortality at 14 days from randomization or hospital discharge [Time frame: 14 days]
- Duration of delirium, defined as number of days CAM-ICU positive [Time frame: 14 days]
- ICU length of stay [Time frame: 14 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Centennial Medical Center — Nashville
Identifiers
NCT: NCT05069428 · 2021-438