Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 104
- 试验地点
- 6
- 主要终点
- Duration of delirium
研究概览
简要总结
Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.
详细描述
Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.
Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU.
Intervention: Increasing dosage of rivastigmine or placebo as add-on medication.
Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months.
Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs.
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
- •18 years or older
- •Positive CAM-ICU
排除标准
- •Known allergy to rivastigmine
- •Unable to receive enteric medication
- •Pregnant or lactating
- •Renal replacement therapy
- •Hepatic encephalopathy
- •Second or third degree atrioventricular block
- •Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
- •Parkinson's disease.
- •Lewy body dementia.
- •ECG QT interval above 500 msec.
- •No informed consent
研究组 & 干预措施
1
Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Rivastigmine: two times 1,5 mg a day; The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
干预措施: Rivastigmine (Drug)
2
Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of delirium
时间窗: 3 months
次要结局
- Severity of delirium(3 months)
- Use of physical restraints(3 months)
- Use of escape medication (i.c. Haloperidol or benzodiazepines)(3 months)
- Number of accidental removed catheters(3 months)
- Length of ICU stay(3 months)
- Length of in-hospital stay(3 months)
- Cognitive outcomes(3 months)
- Activity of daily living(3 months)
- Healthcare costs(3 months)
- Frequency and distribution of side effects(3 months)