NCT00599287终止3 期
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- duration of delirium
研究概览
简要总结
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.
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
- Single (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
- •Older than 18 years
- •Diagnosed as hypoactive delirium
- •Informed consent given
排除标准
- •Pregnancy
- •M. Parkinson
- •Lewy-body dementia
- •Prolonged QT-time
- •Known allergy to the medicinals used
- •Renal replacement therapy
- •Hepatic encephalopathy
- •Hyperthyroid
- •Previous suicide attempts
- •Syndrome of Gilles de la Tourette
- •Patients which cannot receive the medication oral or through a nasogastric tube
研究组 & 干预措施
2
Experimental
Methylphenidate
干预措施: Methylphenidate (Drug)
3
Experimental
Rivastigmine
干预措施: Rivastigmine (Drug)
4
Experimental
Haloperidol
干预措施: Haloperidol (Drug)
结局指标
主要结局
duration of delirium
时间窗: Days
次要结局
- delirium severity(duration of delirium)
- frequency of side effects(duration of intervention)
- duration of ICU-stay(days)
- duration of in hospital stay(days)
研究者
研究点 (1)
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