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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02826356
Other study ID # 69HCL16_0430
Secondary ID
Status Completed
Phase N/A
First received July 5, 2016
Last updated July 7, 2016
Start date February 2016
Est. completion date March 2016

Study information

Verified date July 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Step of the care allowing the patients to benefit from a specific treatment. 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. October 2010 to December 2014 No
Secondary Epidemiological characteristics The investigators collect data such as age, sex, localization of the angioedema. October 2010 to December 2014 No
Secondary Triggering treatments The investigators detail which ACE-inhibitor, which ARB and eventually which co-medication was taken and triggered the angioedema. October 2010 to December 2014 No