Delirium Reduction With Ramelteon
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Days alive without delirium or coma in the ICU
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
placebo
placebo powder equivalent grams at 20:30
干预措施: Ramelteon 8mg (Drug)
ramelteon
ramelteon 8 mg crushed tablet daily at 20:30
干预措施: Ramelteon 8mg (Drug)
结局指标
主要结局
Days alive without delirium or coma in the ICU
时间窗: 14 days
joint modeling approach taking account recurrence and terminating events
次要结局
- ICU length of stay(14 days)
- Mean daily Confusion Assessment Method -7 CAM-ICU-7 score(14 days)
- Incidence of delirium, as defined by a positive CAM-ICU-7(14 days)
- Mortality at 14 days from randomization or hospital discharge(14 days)
- Duration of delirium, defined as number of days CAM-ICU positive(14 days)
研究者
Jennifer Johnson MD
MD
Centennial Medical Center