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NCT03525496 Clinical Trial

Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Allergic Reaction Clinical Trial

— DHIODE  

Official title:
Interest of Challenge Tests for Diagnosis of Immediate Hypersensitivity Against Iodinated Contrast Agents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03525496
Other study ID # 2018-01Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 4, 2018
Est. completion date August 1, 2018

Study information
Verified date April 2018
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Iodinated contrast agents (ICA) are widely used in medical imaging. They provide however a risk of immediate hypersensitivity reactions (IHS). The risk of anaphylactic shock is estimated at 1/100 000 injections. Nevertheless, for safety reasons and to limit undesirable effects, the reintroduction tests are not conducted along similar lines to throughout scan or arteriography. Moreover, reintroduction protocols are actually not standardized, in terms of injected volume and doses progression. It should be evaluated the relevance of the reintroduction tests with injection of a low volume and ensure the absence of reaction during the ICA injections Under real conditions.

The investigators are assuming that the realization of a provocation test by intravenous reintroduction with a reduced dose of ICA improves the predictive value of IHS in comparison with only cutaneous tests.

Description:

The main objective of this study will be to estimate the negative predictive value of the combination of cutaneous tests and provocation test by intravenous reintroduction in the IHS to iodinated contrast agents.

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date August 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Major patient

- Having suffered single-blind reintroduction

- Having benefited from cutaneous tests and ICA reintroduction test in the framework of IHS

Exclusion Criteria:

- Patient with delayed hypersensitivity

- Opposed to use data

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHR Metz-Thionville Metz Moselle

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of immediate hypersensitivity reactions Occurrence of immediate hypersensitivity reactions after an injection of ICA Day 1
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