Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT03426735
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Iodine Contrast Media Extravasation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time resolution the swelling and pain.', 'timeFrame': '24-48 hours past'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iodine', 'Iodized', 'Computerized Tomography', 'Extravasation', 'contrast media'], 'conditions': ['Contrast Media Extravasation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWhen 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Computed tomography procedure.\n* Administration of the contrast medium with injection pump between 1,5 and 8 ml/s.\n* Peripheral venous access in the arms or legs.\n\nExclusion Criteria:\n\n* Administration of the contrast medium with central venous access.\n* Renal insufficiency.\n* Iodine allergy.\n* Immediate acute complications.'}, 'identificationModule': {'nctId': 'NCT03426735', 'briefTitle': 'Study of Iodine Contrast Media Extravasation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Sant Pau'}, 'officialTitle': 'Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.', 'orgStudyIdInfo': {'id': 'EC/16/258/4709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry heat', 'description': 'Dry heat application with a termal bag', 'interventionNames': ['Other: Dry heat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry cold', 'description': 'Dry cold application with a termal bag', 'interventionNames': ['Other: Dry cold']}], 'interventions': [{'name': 'Dry heat', 'type': 'OTHER', '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.', 'armGroupLabels': ['Dry heat']}, {'name': 'Dry cold', 'type': 'OTHER', '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.', 'armGroupLabels': ['Dry cold']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08906', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General de l´Hospitalet', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Health Diagnostic General Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Joan Despí Moisès Broggi', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Radiología del Parc Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Health Diagnostic Teknon', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Servicio Radiologia Clínica Sagrada Familia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08029', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Health Diagnostics Sagrat Cor', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centre de Diagnòstic per la Imatge Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Sant Pau', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiology Nurse', 'investigatorFullName': 'Jaume Roca Sarsanedas', 'investigatorAffiliation': 'Hospital de Sant Pau'}}}}