Prevention of Delirium in Intensive Care by Melatonin: a Prospective, Multicentre, Randomized, Double Blind, Placebo, Multi-arm, Multi-stage Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Delirium incidence
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, Phase 2b/3 two-part adaptive clinical trial. The trial is designed to investigate the pharmacokinetics and the efficacy of multiple dosing regimens of melatonin and to confirm the efficacy and safety of one dosing regimen in prevention for delirium.
详细描述
Treatment of the study is a single daily fixed-hour (21h) dose of 15 mL of an oral syrup, at one of the 3 following concentrations of melatonin: 0 mg/ml i.e. 0 mg/day (placebo); 0.02 mg/ml, i.e. 0.3 mg/day (low dose of melatonin) or 0.2 mg/ml, i.e. 3 mg/day (high dose of melatonin). The three dosages will be identical in appearance and volume.Treatment will be administered up to Day-14 (or death or discharge if these occur before Day-14). Randomization will be stratified by center.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥18 years
- •Patient under invasive mechanical ventilation
- •Anticipated stay in intensive care unit of at least 48 hours
- •Informed consent signed by the patient or a relative or emergency consent
排除标准
- •Invasive mechanical ventilation for more than 48 hours
- •known pregnancy or breastfeeding
- •No understanding of the French language, deafness
- •Dementia (Mini Mental State <20) or known chronic psychosis
- •Delirium (positive CAM-ICU score) before or at the time of randomization
- •Alcohol withdrawal syndrome before or at the time of randomization with Cushman score ≥5
- •Inability to use the enteral route, food intolerance with vomiting
- •Severe hepatic insufficiency (prothrombin level <30%)
- •Ongoing treatment with melatonin or a drug that interacts or modifies its metabolism (fluvoxamine, 5- or 8-methoxypsoralen, estrogen, cimetidine, carbamazepine, rifampicin)
- •known allergy to melatonin
- •moribund state
- •Patient admitted to intensive care for cardiopulmonary arrest, stroke, head trauma, neurosurgery.
- •Patient not affiliated to social security
- •Patient participating in another interventional clinical study with melatonin and / or for whom delirium is the primary endpoint
研究组 & 干预措施
PLACEBO
Daily administration of identical placebo up to 14 days.
干预措施: PLACEBO (Drug)
MELATONIN (LOW DOSE)
Daily administration of melatonin by enteral route at 0.3 mg/day (low dose arm), up to 14 days.
干预措施: MELATONIN (LOW DOSE) (Drug)
MELATONIN (HIGH DOSE)
Daily administration of melatonin by enteral route at 3 mg/day (high dose arm), up to 14 days.
干预措施: MELATONIN (HIGH DOSE) (Drug)
结局指标
主要结局
Delirium incidence
时间窗: up to 14 days
次要结局
- Hospital length of stay(at day 28)
- Duration of delirium(14 days)
- Day 28 Mortality(at day 28)
- Hospital mortality(At day 28)
- ICU mortality(at day 28)
- Evaluate number of days alive without coma nor delirium(Up to day 14)
- Duration of mechanical ventilation(Up to day 28)