Vein Infusion PhlebitisVeinIPPNCT04658758
The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
An observational study of Vein Infusion Phlebitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Vein Infusion Phlebitis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2020to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients aged > 70 years.
Who may be able to join
- Patients aged > 70 years;
- Undergo intravenous continuous or intermittent proton pump inhibitor therapy;
- Patients being informed and not opposed to the study.
Who cannot join
- Existing vein infusion phlebitis before the PPI infusion by intravenous route;
- Under guardianship or curators;
- Covered by french AME health system.
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, 92100
About this study
Official title: 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.
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.
- Conditions
- Vein Infusion Phlebitis
- Keywords
- vein infusion phlebitis, proton pump inhibitor therapy, intravenous infusion, ulcer bleeding, aging
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of infusion phlebitis
The Visual Infusion Phlebitis Scale will be used to define.
Measured: at day-5
Secondary outcomes (1)
Factors of risk of vein infusion phlebitis
To determinate risk factors for vein infusion phlebitis.
Measured: Throughout of the study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start4 Dec 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vein Infusion PhlebitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion PEPIN, MD, PhD, Principal investigator, Geriatric Department, Ambroise Paré Hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658758
- Sponsor's protocol ID
- APHP201085
- Other IDs
- 2020-A02319-30
- Acronym
- VeinIPP
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2020
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
- ClinicalTrials.gov ID
- NCT04658758
- Acronym / sponsor ID
- VeinIPP / APHP201085
- Conditions
- Vein Infusion Phlebitis
- Keywords
- vein infusion phlebitis, proton pump inhibitor therapy, intravenous infusion, ulcer bleeding, aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients aged > 70 years.
Key inclusion criteria (3 listed)
- Patients aged > 70 years;
- Undergo intravenous continuous or intermittent proton pump inhibitor therapy;
- Patients being informed and not opposed to the study.
Key exclusion criteria (3 listed)
- Existing vein infusion phlebitis before the PPI infusion by intravenous route;
- Under guardianship or curators;
- Covered by french AME health system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurence of infusion phlebitis
Time frame: at day-5
The Visual Infusion Phlebitis Scale will be used to define.
1 secondary outcome
Factors of risk of vein infusion phlebitis
Time frame: Throughout of the study, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion PEPIN, MD, PhD principal investigator
Geriatric Department, Ambroise Paré Hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vein Infusion Phlebitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of infusion phlebitis (time frame: at day-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.