EUCTR2011-004762-15-NL进行中（未招募）不适用
Early pharmacological intervention to prevent delirium: HAlopeRidol PrOphylaxis in Older emergency department patieNts.The HARPOON study - Haloperidol prophylaxis in older acutely admitted patients
VU Univeristy Medical Centre0 个研究点开始时间: 2012年5月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •- Patients aged 70 years or over;
- •- The patient is at increased risk for developing in-hospital delirium on admission according to one or more positive answers on the VMS delirium-risk questions;
- •- The patient or proxy is able to provide written informed consent;
- •- The patient or proxy speaks either Dutch or English;
- •- The patient is admitted to the hospital for an internal or surgical specialty.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 780
排除标准
- •- Patients presenting in the ED with delirium according to the DSM-IV criteria;
- •- Patients with clinically significant (cardiac) disorders: QTc interval prolongation (QTc = 500ms), recent acute myocardial infarction, uncompensated heart failure (working diagnosis), acute coronary syndrome (ACS), arrhythmias treated with class IA and III antiarrhythmic medicinal products, history of ventricular arrhythmia, history of torsade de pointes, clinically significant bradycardia, second or third degree heart block, uncorrected hypokalaemia (potassium level 3.0 or lower);
- •- Patients with vascular dementia;
- •- Patients with Lewy Body dementia;
- •- Patients with Parkinson (dementia);
- •- Patients with (a history of) hypokinetic movement disorders;
- •- Patients with (a history of) malignant neuroleptic syndrome;
- •- Patients with (a history of) serotonergic syndrome;
- •- Patients with (a history of) central anticholinergic syndrome;
- •- Patients who will be admitted to the oncology ward;
- •- Patients who have been previously enrolled in the HARPOON study, or who are currently enrolled in other medical- or drug (intervention) studies;
- •- Patients using medications of which concomitant use with haloperidol and/or use during the 7-day intervention period according to protocol (SOP comedication) is contraindicated. Patients using QTc prolonging drugs at presentation with QTc =450ms (men) / QTc =460ms (women) on baseline ECG may be included in the study with repetitive ECG control according to protocol;
- •- Epilepsy
- •- Substance abuse and dependence (DSM-IV criteria);
- •- Patients who are not able to take study medication according to the protocol.
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