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临床试验/NCT01539733
NCT01539733已完成不适用

Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
2
主要终点
DRS-R-98 severity rating score

研究概览

简要总结

The investigators designed a randomised multicenter clinical trial for patients with advanced cancer who are admitted to the medical oncology ward or high-care hospice. On admission all patients with advanced cancer will be asked to participate in this study. Consenting patients will be submitted to delirium observation screening according to the DOS. Subsequently DOS screening will be performed twice weekly until discharge. Each patient who's score is > 3 (DOS positive) is showing significant symptoms of delirium and will be submitted to the revised Delirium Rating Scale (DRS-R-98) to confirm diagnosis. To test validity of the DOS scale for this particular population, each DOS positive score will be randomly matched with a patient with a DOS score < 3 (DOSnegative) and this patient will also be submitted to DRS-R-98. When diagnosis of delirium is confirmed by DRS-98, patients will be randomised between treatment of delirium with olanzapine or haloperidol (usual care). Treatment in both groups will consist of identification and management of underlying aetiologies of delirium if possible and adding neuroleptic medication for symptom control. Patients who recover from their delirium episode as well as their caregivers will be asked to complete the Delirium Experience Questionnaire (DEQ) to assess recall of the delirium experience and the degree of distress related to the delirium episode.

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

入选标准

  • Patient has been diagnosed with advanced cancer
  • Patient or his / her significant other speaks Dutch fluently

排除标准

  • Delirium is due to alcohol withdrawal
  • Patient has been diagnosed with glaucoma, Parkinson's disease or dementia
  • Patient is being treated with other neuroleptic medication or lithium
  • Patient has another psychiatric disorder that is considered (by investigator) to interfere with assessment of delirium
  • Patient had a QTc-interval of > 480 msec on ECG made on admission to the medical oncology ward (ECG is not required if patient is admitted to a high-care hospice)
  • Patient has a history of neuroleptic malignant syndrome
  • Patient has a history of convulsions.

研究组 & 干预措施

Olanzapine

Experimental

干预措施: Olanzapine (Drug)

Haloperidol

Active Comparator

干预措施: Haloperidol (Drug)

结局指标

主要结局

DRS-R-98 severity rating score

时间窗: Until clearance of the delirium signs or for a maximum of 2 weeks

Primary endpoint for this trial is a DRS-R-98 severity rating score \<15,25, as this is a measure for establishing clearance of delirium.

次要结局

  • Delirium resolution rate(Until clearance of the delirium signs or for a maximum of 2 weeks)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

H.M.W. Verheul

Prof. dr.

Amsterdam UMC, location VUmc

研究点 (2)

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