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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT02826356
Collaborator
(none)
38
1
29
39.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Efficient Treatments for ACE-I and ARB-induced Angioedema Exist and Should be Available to All Patients. Analysis of Their Availability and Influencing Factors in the Area Around Lyon, France
    Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Mar 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Epidemiological characteristics [October 2010 to December 2014]

      The investigators collect data such as age, sex, localization of the angioedema.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France. Lyon France 69003

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    • Principal Investigator: Bernard FLOCCARD, MD, Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT02826356
    Other Study ID Numbers:
    • 69HCL16_0430
    First Posted:
    Jul 11, 2016
    Last Update Posted:
    Jul 11, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Hospices Civils de Lyon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2016