Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

November 17, 2010 updated by: Chulalongkorn University
The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with history of immediate hypersensitivity reactions to iodinated contrast media
  2. 15-70 years of age

Exclusion Criteria:

  1. On antihistamine/ cannot discontinue antihistamine before the test
  2. Having asthma exacerbation
  3. Being pregnant
  4. Suffering from severe systemic disease/ in bad health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Healthy controls
Procedure: Skin tests with radiocontrast media
Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media
Active Comparator: Patients with immediate reactions
Procedure: Skin tests with radiocontrast media
Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood in vitro test from patients with a history of immediate reactions to radiocontrast media
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Kiat Ruxrungtham, MD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chula-ARC 003/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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