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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03525496

Acronym

DHIODE

Enrollment

Registered

2018-05-15

Start date

2018-05-04

Completion date

2018-08-01

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Reaction

Keywords

Iodinated contrast agents, Immediate hypersensitivity reactions, Reintroduction tests

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of immediate hypersensitivity reactions	Day 1	Occurrence of immediate hypersensitivity reactions after an injection of ICA

Countries

France

Outcome results