Study of Iodine Contrast Media Extravasation

Not Applicable

Completed

• Conditions: Contrast Media Extravasation
• Interventions: Other: Dry cold; Other: Dry heat

• Registration Number: NCT03426735
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Primary Completion: 2020-07-30
• Study Completion: 2020-11-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-14
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry cold	Dry cold	Dry cold application with a termal bag
Dry heat	Dry heat	Dry heat application with a termal bag

Primary Outcome Measures

Name	Time	Method
Time resolution the swelling and pain.	24-48 hours past

Trial Locations

Locations (9)

Servicio Radiologia Clínica Sagrada Familia; 🇪🇸 Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Health Diagnostic General Catalunya; 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain

Health Diagnostic Teknon; 🇪🇸 Barcelona, Spain

Radiología del Parc Salut Mar; 🇪🇸 Barcelona, Spain

Hospital General de l´Hospitalet; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Health Diagnostics Sagrat Cor; 🇪🇸 Barcelona, Spain

Centre de Diagnòstic per la Imatge Clínic; 🇪🇸 Barcelona, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain