EUCTR2017-001260-37-NL进行中（未招募）1 期
PRODEO: PROfylactic Haloperidol in patients defined as high risk for DElirium with delirium risk mOdel - PRODEO
Zuyderland Medical Center0 个研究点开始时间: 2017年5月23日最近更新:
适应症
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age > 60 years
- •Planned elective surgery
- •High-risk of developing delirium according to the DEMO model
- •Absence of delirium pre-operatively
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 366
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •Less than 1-day postoperative admission on ward
- •Hypersensitivity to butyrophenone-derivatives
- •Use of antipsychotics
- •Not being able to take oral medication
- •Presence of contraindications;
- •olesions of the basal ganglia,
- •oclinically significant heart disease,
- •oknown prolongation of the QT interval,
- •ohistory of ventricular arrhythmia and ‘torsades de pointes’,
- •ouncorrected hypokalemia.
研究者
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Effectiveness of haloperidol for the treatment of acute confusional state (delirium) in patients treated at the intensive careDeliriumMedDRA version: 21.0Level: LLTClassification code 10012224Term: Delirium toxicSystem Organ Class: 100000004873MedDRA version: 21.1Level: LLTClassification code 10000702Term: Acute deliriumSystem Organ Class: 100000004873MedDRA version: 21.1Level: LLTClassification code 10042275Term: Subacute deliriumSystem Organ Class: 100000004873MedDRA version: 21.0Level: LLTClassification code 10012220Term: Delirium due to a general medical conditionSystem Organ Class: 100000004873MedDRA version: 21.0Level: LLTClassification code 10012226Term: Delirium, cause unknownSystem Organ Class: 100000004873MedDRA version: 21.0Level: LLTClassification code 10071313Term: Hypoactive deliriumSystem Organ Class: 100000004873MedDRA version: 21.0Level: LLTClassification code 10071314Term: Hyperactive deliriumSystem Organ Class: 100000004873MedDRA version: 21.0Level: LLTClassification code 10071315Term: Mixed deliriumSystem Organ Class: 100000004873EUCTR2017-003115-20-NLErasmus Medical Center Rotterdam742