Skip to main content
OpenTrials
Completed

NCT Number: NCT02826356

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Study type

Observational

Primary location

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

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Step of the care allowing the patients to benefit from a specific treatment.

    Time frame: 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 outcomes

  1. Epidemiological characteristics

    Time frame: October 2010 to December 2014

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

  2. Triggering treatments

    Time frame: October 2010 to December 2014

    The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

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.