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

December 11, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Geriatric Department, Ambroise Paré Hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients aged > 70 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of infusion phlebitis
Time Frame: at day-5
The Visual Infusion Phlebitis Scale will be used to define.
at day-5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors of risk of vein infusion phlebitis
Time Frame: Throughout of the study, an average of 1 year
To determinate risk factors for vein infusion phlebitis.
Throughout of the study, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marion PEPIN, MD, PhD, Geriatric Department, Ambroise Paré Hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • APHP201085
  • 2020-A02319-30 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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