Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT04658758
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of infusion phlebitis', 'timeFrame': 'at day-5', 'description': 'The Visual Infusion Phlebitis Scale will be used to define.'}], 'secondaryOutcomes': [{'measure': 'Factors of risk of vein infusion phlebitis', 'timeFrame': 'Throughout of the study, an average of 1 year', 'description': 'To determinate risk factors for vein infusion phlebitis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vein infusion phlebitis', 'proton pump inhibitor therapy', 'intravenous infusion', 'ulcer bleeding', 'aging'], 'conditions': ['Vein Infusion Phlebitis']}, 'descriptionModule': {'briefSummary': '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).\n\nThe primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people.\n\nThe secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients aged \\> 70 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 70 years;\n* Undergo intravenous continuous or intermittent proton pump inhibitor therapy;\n* Patients being informed and not opposed to the study.\n\nExclusion Criteria:\n\n* Existing vein infusion phlebitis before the PPI infusion by intravenous route;\n* Under guardianship or curators;\n* Covered by french AME health system.'}, 'identificationModule': {'nctId': 'NCT04658758', 'acronym': 'VeinIPP', 'briefTitle': 'The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors', 'orgStudyIdInfo': {'id': 'APHP201085'}, 'secondaryIdInfos': [{'id': '2020-A02319-30', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Geriatric Department, Ambroise Paré Hospital, APHP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'overallOfficials': [{'name': 'Marion PEPIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geriatric Department, Ambroise Paré Hospital, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}