Study of Iodine Contrast Media Extravasation

Santa Creu and Sant Pau Hospital

Status: Completed

Conditions: Contrast Media Extravasation

Treatments: Other: Dry cold; Other: Dry heat

Study type: Interventional

Funder types: Other

Identifiers

NCT03426735

EC/16/258/4709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Dry heat

Experimental group

Description:

Dry heat application with a termal bag

Treatment:

Other: Dry heat

Dry cold

Active Comparator group

Description:

Dry cold application with a termal bag

Treatment:

Other: Dry cold