Study of Iodine Contrast Media Extravasation
Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
1 other identifier
interventional
65
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2017
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedFebruary 16, 2021
February 1, 2021
3.2 years
January 29, 2018
February 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time resolution the swelling and pain.
24-48 hours past
Study Arms (2)
Dry heat
EXPERIMENTALDry heat application with a termal bag
Dry cold
ACTIVE COMPARATORDry cold application with a termal bag
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Administration of the contrast medium with central venous access.
- Renal insufficiency.
- Iodine allergy.
- Immediate acute complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Sant Paulead
- University of Barcelonacollaborator
Study Sites (9)
Hospital General de l´Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Health Diagnostic General Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Radiología del Parc Salut Mar
Barcelona, 08003, Spain
Health Diagnostic Teknon
Barcelona, 08022, Spain
Servicio Radiologia Clínica Sagrada Familia
Barcelona, 08022, Spain
Health Diagnostics Sagrat Cor
Barcelona, 08029, Spain
Centre de Diagnòstic per la Imatge Clínic
Barcelona, 08036, Spain
Hospital Sant Pau
Barcelona, 08041, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiology Nurse
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 8, 2018
Study Start
June 6, 2017
Primary Completion
July 30, 2020
Study Completion
November 30, 2020
Last Updated
February 16, 2021
Record last verified: 2021-02