Study of Iodine Contrast Media Extravasation

Study Overview
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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.

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

Conditions
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Contrast Media Extravasation

Intervention / Treatment
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* Other: Dry heat
* Other: Dry cold


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry heat<br>Dry heat application with a termal bag | Other: Dry heat<br>* 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.<br>|
| Active Comparator: Dry cold<br>Dry cold application with a termal bag | Other: Dry cold<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time resolution the swelling and pain. |  | 24-48 hours past | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodine, Iodized, Computerized Tomography, Extravasation, contrast media