Study of Iodine Contrast Media Extravasation

Contrast Media Extravasation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426735
• Other study ID #: EC/16/258/4709
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Hospital de Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Media Extravasation
• Extravasation of Diagnostic and Therapeutic Materials

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Centre de Diagnòstic per la Imatge Clínic	Barcelona
Spain	Health Diagnostic Teknon	Barcelona
Spain	Health Diagnostics Sagrat Cor	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Radiología del Parc Salut Mar	Barcelona
Spain	Servicio Radiologia Clínica Sagrada Familia	Barcelona
Spain	Hospital General de l´Hospitalet	Hospitalet de Llobregat	Barcelona
Spain	Health Diagnostic General Catalunya	Sant Cugat del Vallès	Barcelona
Spain	Hospital de Sant Joan Despí Moisès Broggi	Sant Joan Despí	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Sant Pau	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time resolution the swelling and pain.		24-48 hours past