DELIRE-ICU: A Randomised Controlled Feasibility Trial of Melatonin vs Placebo in the Treatment of Delirium in the Intensive Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical: Duration of delirium
研究概览
简要总结
The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.
详细描述
The prevalence of delirium is high in the intensive care unit (ICU), yet there is no pharmacological treatment that has been proven effective. The investigators hypothesize that melatonin, given on a daily basis at 21:00, will safely decrease the mean duration of a delirium episode in ICU patients. The current literature evaluating melatonin as a treatment for delirium is lacking, therefore more studies are needed.
It is estimated that an alteration of sleep pattern can be found in up to 75% of patients with delirium. This raises the hypothesis that prevention and treatment of sleep disorders could potentially improve delirium. Sleep and circadian rhythm disturbances are associated with low endogenous melatonin secretion and studies have shown that it also occurs in patients with delirium.
Thus, the objective is to conduct a phase II double blind, placebo-controlled randomized trial comparing melatonin 9 mg to placebo to evaluate the feasibility of a future large-scale RCT. Participants will be followed during their stay in the ICU and after their transfer on another unit up to a maximum of 14 days. Feasibility of the larger trial will mainly be based on enrollment rates.
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)
盲法说明
All study personnel, care provider, patients and their families will remain blinded. Randomization will be performed by members of the Pharmacy Research Department.
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
- •Patients aged 18 years or older admitted to the intensive care unit;
- •Anticipated ICU stay > 48 hours;
- •ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization.
排除标准
- •Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®;
- •Use of melatonin within 24 hours prior to randomization;
- •Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy;
- •Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal;
- •Presence of active seizures, coma, aphasia or severe intellectual disability;
- •Limited short-term vital prognosis;
- •Diagnosis of delirium prior to ICU admission;
- •Pregnancy or breastfeeding;
- •Absolute contraindication to receive enteral medication;
- •Inability to understand or speak English or French;
- •Total blindness.
研究组 & 干预措施
Enteral melatonin 9 mg
Melatonin 9 mg from a 1 mg/mL oral suspension of melatonin in ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
干预措施: Melatonin (Drug)
Enteral placebo
ORA-BLEND SF® (sugar-free flavoured suspending vehicle). Final volume in the oral syringe will be 9 mL.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical: Duration of delirium
时间窗: 14 days
Compare the average duration of an episode of delirium defined as the number of days with ICDSC score ≥4 between the 2 groups.
Feasibility: Enrollment rate
时间窗: 8 months
Average enrollment rate of participants per month.
次要结局
- Feasibility: Study adherence(8 months)
- Feasibility: Consent rate(8 months)
- Clinical: Adverse events(14 days)