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Study of Iodine Contrast Media Extravasation

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ClinicalTrials.gov Identifier: NCT03426735
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Jaume Roca Sarsanedas, Hospital de Sant Pau

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: 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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

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.



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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


Contacts
Contact: Jaume Roca +34601014852 jroca@santpau.cat

Locations
Spain
Health Diagnostic General Catalunya Recruiting
Sant Cugat del Vallès, Barcelona, Spain, 08195
Contact: Jose A. Calero         
Radiología del Parc Salut Mar Recruiting
Barcelona, Spain, 08003
Contact: Clara Serlavos         
Contact: Toni Figueres         
Health Diagnostic Teknon Recruiting
Barcelona, Spain, 08022
Contact: Susana Díaz         
Servicio Radiologia Clínica Sagrada Familia Recruiting
Barcelona, Spain, 08022
Contact: Francesc Miras         
Contact: Jaume Llauger         
Centre de Diagnòstic ARVI S.A. Recruiting
Barcelona, Spain, 08023
Contact: Nuria Vives         
Health Diagnostics Sagrat Cor Recruiting
Barcelona, Spain, 08029
Contact: Carlos Garcia         
Centre de Diagnòstic per la Imatge Clínic Recruiting
Barcelona, Spain, 08036
Contact: Pedro Sanz         
Hospital Sant Pau Recruiting
Barcelona, Spain, 08041
Contact: Jaume Roca         
Sponsors and Collaborators
Hospital de Sant Pau
University of Barcelona

Responsible Party: Jaume Roca Sarsanedas, Radiology Nurse, Hospital de Sant Pau
ClinicalTrials.gov Identifier: NCT03426735     History of Changes
Other Study ID Numbers: EC/16/258/4709
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

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:
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries