ClinicalTrials.gg
CompletedNCT04658758VeinIPPUpdated Mar 18, 2025

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

An observational study in Vein Infusion Phlebitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vein Infusion Phlebitis

Browse trials for

Keywords

  • vein infusion phlebitis
  • proton pump inhibitor therapy
  • intravenous infusion
  • ulcer bleeding
  • aging
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

Browse Phlebitis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitalized patients aged > 70 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Existing vein infusion phlebitis before the PPI infusion by intravenous route;
  • Under guardianship or curators;
  • Covered by french AME health system.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Occurence of infusion phlebitis

    The Visual Infusion Phlebitis Scale will be used to define.

    Time frame: at day-5

Secondary outcomes

  1. Factors of risk of vein infusion phlebitis

    To determinate risk factors for vein infusion phlebitis.

    Time frame: Throughout of the study, an average of 1 year

07

Study locations

1 site
  • Geriatric Department, Ambroise Paré Hospital, APHP
    Boulogne-Billancourt, 92100, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04658758
Responsible party
Sponsor
First posted
Dec 8, 2020
Start date
Dec 4, 2020
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Last update
Mar 18, 2025

Study contacts

Marion PEPIN, MD, PhD
principal investigator · Geriatric Department, Ambroise Paré Hospital, APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion