Study of Iodine Contrast Media Extravasation
Primary Purpose
Contrast Media Extravasation
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry heat
Dry cold
Sponsored by
About this trial
This is an interventional treatment trial for Contrast Media Extravasation focused on measuring Iodine, Iodized, Computerized Tomography, Extravasation, contrast media
Eligibility Criteria
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.
Sites / Locations
- Hospital General de l´Hospitalet
- Health Diagnostic General Catalunya
- Hospital de Sant Joan Despí Moisès Broggi
- Radiología del Parc Salut Mar
- Health Diagnostic Teknon
- Servicio Radiologia Clínica Sagrada Familia
- Health Diagnostics Sagrat Cor
- Centre de Diagnòstic per la Imatge Clínic
- Hospital Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dry heat
Dry cold
Arm Description
Dry heat application with a termal bag
Dry cold application with a termal bag
Outcomes
Primary Outcome Measures
Time resolution the swelling and pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT03426735
First Posted
January 29, 2018
Last Updated
February 14, 2021
Sponsor
Hospital de Sant Pau
Collaborators
University of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03426735
Brief Title
Study of Iodine Contrast Media Extravasation
Official Title
Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Sant Pau
Collaborators
University of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Media Extravasation
Keywords
Iodine, Iodized, Computerized Tomography, Extravasation, contrast media
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry heat
Arm Type
Experimental
Arm Description
Dry heat application with a termal bag
Arm Title
Dry cold
Arm Type
Active Comparator
Arm Description
Dry cold application with a termal bag
Intervention Type
Other
Intervention Name(s)
Dry heat
Intervention Description
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
Intervention Name(s)
Dry cold
Intervention Description
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 Outcome Measure Information:
Title
Time resolution the swelling and pain.
Time Frame
24-48 hours past
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital General de l´Hospitalet
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Health Diagnostic General Catalunya
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital de Sant Joan Despí Moisès Broggi
City
Sant Joan Despí
State/Province
Barcelona
ZIP/Postal Code
08970
Country
Spain
Facility Name
Radiología del Parc Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Health Diagnostic Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Servicio Radiologia Clínica Sagrada Familia
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Health Diagnostics Sagrat Cor
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
Facility Name
Centre de Diagnòstic per la Imatge Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
12. IPD Sharing Statement
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Study of Iodine Contrast Media Extravasation
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