- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04658758
The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors (VeinIPP)
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
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marion PEPIN, MD, PhD
- Phone Number: +33 (0)1 49 09 45 51
- Email: marion.pepin@aphp.fr
Study Locations
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Boulogne-Billancourt, France, 92100
- Recruiting
- Geriatric Department, Ambroise Paré Hospital, APHP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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at day-5
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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
Investigators
- Principal Investigator: Marion PEPIN, MD, PhD, Geriatric Department, Ambroise Paré Hospital, APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP201085
- 2020-A02319-30 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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