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NCT05537194 Clinical Trial

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

Hypoxia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05537194
Other study ID # Pharmaco 20220908
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 1963
Est. completion date August 14, 2022

Study information
Verified date September 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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®).

Recruitment information / eligibility
Status Completed
Enrollment 32000000
Est. completion date August 14, 2022
Est. primary completion date August 14, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - present in the database Exclusion Criteria: - chronology not compatible with the drug imputability

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dihydropyridine calcium channel inhibitors use
administration of dihydropyridine calcium channel inhibitors

Locations
Country Name City State
France Caen University Hospital, Department of Pharmacology Caen Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary association between dihydropyridine CCI or urapidil and hypoxia from the 01/01/1963 to the 14/08/2022
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