The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Delirium- and coma-free days
研究概览
简要总结
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.
详细描述
Rationale:
Many pharmacologic agents have been studied to reduce delirium in high risk patients, but the data has not shown significant or clinically important outcomes. These agents also have more side effect profiles such as arrhythmia and QT prolongation. Ramelteon is an effective drug to improve sleep quality and has a low side effect profile. Improved sleep quality and reduced delirium in ICU population will lead to improved acute and long-term outcomes of the patients and lower delirium-related healthcare cost.
Study Hypothesis:
It is hypothesized that those receiving ramelteon will have a higher rate of delirium- and coma-free days, on average, than those receiving placebo. We also hypothesize that those receiving ramelteon will have lower Confusion Assessment Method for Intensive Care Unit-7 (CAM-ICU-7) scores than those receiving placebo, and that the reduction from baseline will be greater for those receiving ramelteon than those receiving placebo. In addition, those receiving ramelteon will be in the medical intensive care unit (MICU) and hospital fewer days than those receiving placebo. Those receiving ramelteon will have more sleep-time and fewer awakenings than those receiving placebo (as defined by the actigraph device). In addition, those receiving ramelteon will have higher subjective quality of sleep than those receiving placebo on patient-reported sleep evaluation questionnaire. Lastly, those receiving ramelteon will suffer less from post-intensive care syndrome compared to those receiving placebo.
Study Procedure:
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
- •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.
排除标准
- •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
研究组 & 干预措施
Mechanically ventilated
Participants who are on mechanical ventilator at the time of study enrollment.
干预措施: Ramelteon (Drug)
Mechanically ventilated
Participants who are on mechanical ventilator at the time of study enrollment.
干预措施: Placebo - Cap (Drug)
Non mechanically ventilated
Participants who are not on mechanical ventilator at the time of study enrollment.
干预措施: Ramelteon (Drug)
Non mechanically ventilated
Participants who are not on mechanical ventilator at the time of study enrollment.
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Delirium- and coma-free days
时间窗: 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).
次要结局
- 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.)
- 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.)
- 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.)
- EQ-5D (Euro Quality of life-5 Dimensions) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group.(At one, three, and six month post ICU discharge.)
- Number of ICU and hospital days.(Until discharge or up to 30 days of hospitalization, whichever is sooner.)
- Telephone Interview for Cognitive Status (TICS) scores at 1-, 3-, and 6-month post ICU discharge in ramelteon group compared to the placebo group.(At one, three, and six month post ICU discharge.)