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

Completed

• Conditions: Vein Infusion Phlebitis

• Registration Number: NCT04658758
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-11-30
• Study Start: 2020-12-04
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-08
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of infusion phlebitis	at day-5	The Visual Infusion Phlebitis Scale will be used to define.

Secondary Outcome Measures

Name	Time	Method
Factors of risk of vein infusion phlebitis	Throughout of the study, an average of 1 year	To determinate risk factors for vein infusion phlebitis.

Trial Locations

Locations (1)

Geriatric Department, Ambroise Paré Hospital, APHP; 🇫🇷 Boulogne-Billancourt, France