Geriatric Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, 92100, France
Completed
NCT Number: NCT04658758
The Incidence and Risk 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.
Completed
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Notify MeKey information
Conditions
Age range
70 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Occurence of infusion phlebitis
Time frame: at day-5
The Visual Infusion Phlebitis Scale will be used to define.
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Official study title
Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
Acronym: VeinIPP
Important dates
- Study start
- 2020
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Dec 8, 2020
- Registry last updated
- Mar 18, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.