Study of Iodine Contrast Media Extravasation

NCT ID: NCT03426735

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Contrast Media Extravasation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dry heat

Dry heat application with a termal bag

Group Type EXPERIMENTAL

Dry heat

Intervention Type OTHER

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 application with a termal bag

Group Type ACTIVE_COMPARATOR

Dry cold

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Barcelona

OTHER

Sponsor Role collaborator

Hospital de Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Jaume Roca Sarsanedas

Radiology Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General de l´Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Health Diagnostic General Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Site Status

Radiología del Parc Salut Mar

Barcelona, , Spain

Site Status

Health Diagnostic Teknon

Barcelona, , Spain

Site Status

Servicio Radiologia Clínica Sagrada Familia

Barcelona, , Spain

Site Status

Health Diagnostics Sagrat Cor

Barcelona, , Spain

Site Status

Centre de Diagnòstic per la Imatge Clínic

Barcelona, , Spain

Site Status

Hospital Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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EC/16/258/4709

Identifier Type: -

Identifier Source: org_study_id

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