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

NCT ID: NCT05537194

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1963-01-01

Study Completion Date

2022-08-14

Brief Summary

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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®).

Detailed Description

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Conditions

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Hypoxia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with hypoxia

dihydropyridine calcium channel inhibitors use

Intervention Type DRUG

administration of dihydropyridine calcium channel inhibitors

Patients without hypoxia

dihydropyridine calcium channel inhibitors use

Intervention Type DRUG

administration of dihydropyridine calcium channel inhibitors

Interventions

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dihydropyridine calcium channel inhibitors use

administration of dihydropyridine calcium channel inhibitors

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* present in the database

Exclusion Criteria

* chronology not compatible with the drug imputability
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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Pharmaco 20220908

Identifier Type: -

Identifier Source: org_study_id

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