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

Vein Infusion Phlebitis Clinical Trial

— VeinIPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658758
• Other study ID #: APHP201085
• Secondary ID: 2020-A02319-30
• Status: Recruiting
• Start date: December 4, 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marion PEPIN, MD, PhD
• Phone: +33 (0)1 49 09 45 51
• Email: marion.pepin[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Phlebitis
• Vein Infusion Phlebitis

Locations

Country	Name	City	State
France	Geriatric Department, Ambroise Paré Hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of infusion phlebitis	The Visual Infusion Phlebitis Scale will be used to define.	at day-5
Secondary	Factors of risk of vein infusion phlebitis	To determinate risk factors for vein infusion phlebitis.	Throughout of the study, an average of 1 year