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Study of Iodine Contrast Media Extravasation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426735
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Jaume Roca Sarsanedas, Hospital de Sant Pau

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contrast Media Extravasation Other: Dry heat Other: Dry cold Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
Actual Study Start Date : June 6, 2017
Actual Primary Completion Date : July 30, 2020
Actual Study Completion Date : November 30, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time resolution the swelling and pain. [ Time Frame: 24-48 hours past ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426735


Locations
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Spain
Hospital General de l´Hospitalet
Hospitalet de Llobregat, Barcelona, Spain, 08906
Health Diagnostic General Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain, 08970
Radiología del Parc Salut Mar
Barcelona, Spain, 08003
Health Diagnostic Teknon
Barcelona, Spain, 08022
Servicio Radiologia Clínica Sagrada Familia
Barcelona, Spain, 08022
Health Diagnostics Sagrat Cor
Barcelona, Spain, 08029
Centre de Diagnòstic per la Imatge Clínic
Barcelona, Spain, 08036
Hospital Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Hospital de Sant Pau
University of Barcelona
More Information
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Responsible Party: Jaume Roca Sarsanedas, Radiology Nurse, Hospital de Sant Pau
ClinicalTrials.gov Identifier: NCT03426735    
Other Study ID Numbers: EC/16/258/4709
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaume Roca Sarsanedas, Hospital de Sant Pau:
Iodine
Iodized
Computerized Tomography
Extravasation
contrast media
Additional relevant MeSH terms:
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Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries