Study of Iodine Contrast Media Extravasation

February 14, 2021 updated by: Jaume Roca Sarsanedas, Hospital de Sant Pau

Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.

The purpose of this study is to determine the best intervention after the extravasation of the iodinated contrast medium out of a vessel into the surrounding tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The risk of intravenous extravasation of iodinated contrast media has a relatively low incidence, although the increase in requests for computed tomography scans where it can manage contrasts with a large volume, high osmolality, high-speed injection pumps and even with an added electrical load, has caused an increase in this risk and its complications.

When there is an extravasation of iodinated contrast medium, in most published recommendations and guidelines advise local conservative measures, but there is no consensus on whether cold or heat should be applied as the first intervention to minimize the consequences and favour a rapid resolution.

This study aims to evaluate the effectiveness of the application of heat in the extravasations of iodinated contrast, providing the necessary evidence to determine the best cure that can be applied in the current circumstances of administration, by injection pumps at high speeds and large volumes.

Study Type

Interventional

Enrollment (Actual)

65

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

  • Spain
      • Barcelona, Spain, 08041
        • Hospital Sant Pau
      • Barcelona, Spain, 08003
        • Radiología del Parc Salut Mar
      • Barcelona, Spain, 08022
        • Health Diagnostic Teknon
      • Barcelona, Spain, 08022
        • Servicio Radiologia Clínica Sagrada Familia
      • Barcelona, Spain, 08029
        • Health Diagnostics Sagrat Cor
      • Barcelona, Spain, 08036
        • Centre de Diagnòstic per la Imatge Clínic
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Hospital General de l´Hospitalet
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Health Diagnostic General Catalunya
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Hospital de Sant Joan Despí Moisès Broggi

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Computed tomography procedure.
  • Administration of the contrast medium with injection pump between 1,5 and 8 ml/s.
  • Peripheral venous access in the arms or legs.

Exclusion Criteria:

  • Administration of the contrast medium with central venous access.
  • Renal insufficiency.
  • Iodine allergy.
  • Immediate acute complications.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry heat
Dry heat application with a termal bag
Other: Dry heat
Dry heat will be applied in the extravasation zone for 10 minutes. Let it rest for 20 and proceed to make a second application of dry cold for another 10 minutes. The control is after 24 hours.
Active Comparator: Dry cold
Dry cold application with a termal bag
Other: Dry cold
Dry cold will be applied in the extravasation zone for 10 minutes. Let it rest for 20 and proceed to make a second application of dry cold for another 10 minutes. The control is after 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time resolution the swelling and pain.
Time Frame: 24-48 hours past
24-48 hours past

Collaborators and Investigators

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

Sponsor

Hospital de Sant Pau

Collaborators

University of Barcelona

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 (Actual)

June 6, 2017

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/16/258/4709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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