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Completed

NCT Number: NCT03426735

Study of Iodine Contrast Media Extravasation

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.

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Key information

Conditions

Contrast Media Extravasation Extravasation of Diagnostic and Therapeutic Materials Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de l´Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dry heat

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

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.

Primary outcomes

  1. Time resolution the swelling and pain.

    Time frame: 24-48 hours past

Sponsors and collaborators

Lead sponsor

Hospital de Sant Pau

Other

Collaborators

  • University of Barcelona

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2018
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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