Contrast Media ExtravasationNCT03426735
Study of Iodine Contrast Media Extravasation
A study testing Dry heat and Dry cold in people with Contrast Media Extravasation, run by Hospital de Sant Pau at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Media Extravasation
- What is being tested?
- Dry heat and Dry cold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesSpain
- Study dates
- 6 Jun 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Administration of the contrast medium with central venous access.
- Renal insufficiency.
- Iodine allergy.
- Immediate acute complications.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Radiología del Parc Salut Mar
Barcelona, 08003
Health Diagnostic Teknon
Barcelona, 08022
Servicio Radiologia Clínica Sagrada Familia
Barcelona, 08022
Health Diagnostics Sagrat Cor
Barcelona, 08029
Centre de Diagnòstic per la Imatge Clínic
Barcelona, 08036
Hospital Sant Pau
Barcelona, 08041
Hospital General de l´Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08906
Health Diagnostic General Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970
About this study
Official title: Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
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.
Read the 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.
- Conditions
- Contrast Media Extravasation
- Being tested
- Dry heat, Dry cold
- Keywords
- Iodine, Iodized, Computerized Tomography, Extravasation, contrast media
- Medical subject headings
- Extravasation of Diagnostic and Therapeutic Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry heatOther
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 coldOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dry heat | Experimental | Dry heat application with a termal bag Receives: Other: Dry heat |
| Dry cold | Active comparator | Dry cold application with a termal bag Receives: Other: Dry cold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time resolution the swelling and pain.
Measured: 24-48 hours past
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start6 Jun 2017
- Primary completion30 Jul 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Media ExtravasationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Jaume Roca Sarsanedas, Hospital de Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426735
- Sponsor's protocol ID
- EC/16/258/4709
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
- ClinicalTrials.gov ID
- NCT03426735
- Acronym / sponsor ID
- EC/16/258/4709
- Conditions
- Contrast Media Extravasation
- Keywords
- Iodine, Iodized, Computerized Tomography, Extravasation, contrast media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospital de Sant PauUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry heat | Experimental | Other: Dry heatDry heat application with a termal bag |
| Dry cold | Active comparator | Other: Dry coldDry cold application with a termal bag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Administration of the contrast medium with central venous access.
- Renal insufficiency.
- Iodine allergy.
- Immediate acute complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry heatDry 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. | Other | Dry heat |
| Dry coldDry 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. | Other | Dry cold |
Primary outcome
Time resolution the swelling and pain.
Time frame: 24-48 hours past
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Related trials for Contrast Media Extravasation
RecruitingObservational study
Risk Prediction Model for Iodinated Contrast Medium Extravasation
Extravasation of Contrast Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry heat and Dry cold in people with Contrast Media Extravasation, run by Hospital de Sant Pau at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time resolution the swelling and pain. (time frame: 24-48 hours past). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021; AzTrials last refreshed its copy on 5 Nov 2026.