Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema

Completed

• Conditions: ACE-I and ARB-induced Angioedema.

• Registration Number: NCT02826356
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-07
• Last Update Submitted: 2016-07-07
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

• Every patient followed for the first time in our reference center for severe confirmed ACE-I or ARB-induced angioedema. Data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit.
• Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.

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Exclusion Criteria

• Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Step of the care allowing the patients to benefit from a specific treatment.	October 2010 to December 2014	Three answers are possible. Patients were treated with the specific medication (icatibant or C1-inhibitor concentrate) either in the first ED or by the medical ambulance team, or by the investigators reference center's intensive care unit.

Secondary Outcome Measures

Name	Time	Method
Epidemiological characteristics	October 2010 to December 2014	The investigators collect data such as age, sex, localization of the angioedema.
Triggering treatments	October 2010 to December 2014	The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema.

Trial Locations

Locations (1)

Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.; 🇫🇷 Lyon, France