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

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®).

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

present in the database

Exclusion criteria

chronology not compatible with the drug imputability

Treatment and study plan

dihydropyridine calcium channel inhibitors use

Drug

administration of dihydropyridine calcium channel inhibitors

Primary outcomes

association between dihydropyridine CCI or urapidil and hypoxia

Time frame: from the 01/01/1963 to the 14/08/2022

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start: 1963
Primary completion: 2022
Study completion: 2022
First posted: Sep 13, 2022
Registry last updated: Sep 13, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed