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临床试验/NCT04658758
NCT04658758已完成不适用

Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Occurence of infusion phlebitis

研究概览

简要总结

Intermittent or continuous proton pump inhibitor (PPI) therapy are recommended for high-risk bleeding ulcers according to the French Society of Gastroenterology. The prevalence of incidence of vein infusion phlebitis after PPI intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis).

The primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people.

The secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

详细描述

This is a multicenter observational study. 5 centers will participate to the study. Aging patients undergoing PPI intravenous infusion therapy will be proposed to be enrolled in the study. Paramedical observation will be performed during 5 days for each enrolled patients.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged > 70 years;
  • Undergo intravenous continuous or intermittent proton pump inhibitor therapy;
  • Patients being informed and not opposed to the study.

排除标准

  • Existing vein infusion phlebitis before the PPI infusion by intravenous route;
  • Under guardianship or curators;
  • Covered by french AME health system.

结局指标

主要结局

Occurence of infusion phlebitis

时间窗: at day-5

The Visual Infusion Phlebitis Scale will be used to define.

次要结局

  • Factors of risk of vein infusion phlebitis(Throughout of the study, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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