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临床试验/NCT02043912
NCT02043912已完成不适用

Drug Interactions With Risk of QT-prolongation in a General Hospital: an Epidemiological Point Prevalence Study

KU Leuven1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2013年7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
KU Leuven
入组人数
222
试验地点
1
主要终点
QTc-interval (corrected for heart rate)

研究概览

简要总结

In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

详细描述

Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

  • The medication profiles will be checked for drug interactions with risk of QT-prolongation.
  • Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
  • Safety measurements (e.g. ECG) will be documented.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • treatment with haloperidol (started in the hospital)

排除标准

  • age < 18 years

研究组 & 干预措施

patients treated with haloperidol

干预措施: Haloperidol (Drug)

结局指标

主要结局

QTc-interval (corrected for heart rate)

时间窗: maximum one year before inclusion / one week after inclusion

次要结局

  • number of drug interactions (with risk of QT-prolongation)(one week before/after inclusion)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eline Vandael

PhD-student

KU Leuven

研究点 (1)

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