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

NCT ID: NCT04658758

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-04

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Vein Infusion Phlebitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion PEPIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Department, Ambroise Paré Hospital, APHP

Locations

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Geriatric Department, Ambroise Paré Hospital, APHP

Boulogne-Billancourt, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02319-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP201085

Identifier Type: -

Identifier Source: org_study_id

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