跳至主要内容
临床试验/NCT05815550
NCT05815550已完成不适用

Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 19,081 人开始时间: 2022年2月9日最近更新:
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
入组人数
19,081
试验地点
1
主要终点
Delirium occuring when using PPI

研究概览

简要总结

Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.

Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.

研究设计

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

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

  • Delirium mentioned in the safety report

排除标准

  • 未提供

研究组 & 干预措施

PPI users

干预措施: PPI (Drug)

结局指标

主要结局

Delirium occuring when using PPI

时间窗: 09/02/2022

次要结局

  • Association between PPI use and occurrence of delirium and hyponatremia(09/02/2022)
  • Association between PPI use and occurrence of delirium(09/02/2022)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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