Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT05537194
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2022-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32000000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1963-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-09-08', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'association between dihydropyridine CCI or urapidil and hypoxia', 'timeFrame': 'from the 01/01/1963 to the 14/08/2022'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Reports in VigiBase', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* present in the database\n\nExclusion Criteria:\n\n* chronology not compatible with the drug imputability'}, 'identificationModule': {'nctId': 'NCT05537194', 'briefTitle': 'Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil', 'orgStudyIdInfo': {'id': 'Pharmaco 20220908'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hypoxia', 'interventionNames': ['Drug: dihydropyridine calcium channel inhibitors use']}, {'label': 'Patients without hypoxia', 'interventionNames': ['Drug: dihydropyridine calcium channel inhibitors use']}], 'interventions': [{'name': 'dihydropyridine calcium channel inhibitors use', 'type': 'DRUG', 'description': 'administration of dihydropyridine calcium channel inhibitors', 'armGroupLabels': ['Patients with hypoxia', 'Patients without hypoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'Caen University Hospital, Department of Pharmacology', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}