Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT03706404
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Colic Fast Track Pathway in the Emergency Department.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-22', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay in the Emergency Department', 'timeFrame': '24 hours'}, {'measure': 'Adverse events', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Number of conclusive exams in the Point-of-Care intervention arm.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Colic', 'Point-of-Care ultrasound', 'Point-of-Care testing'], 'conditions': ['Renal Colic']}, 'referencesModule': {'references': [{'pmid': '33496396', 'type': 'DERIVED', 'citation': 'Tung Chen Y, Rodriguez Fuertes P, Oliver Saez P, Villen Villegas T, Buno Soto A, Fernandez Calle P, Carballo Cardona C, Cobo Mora J, Jaen Canadas M, Yan Tong H, M Borobia A. Efficacy of a fast-track pathway for managing uncomplicated renal or ureteral colic in a hospital emergency department: the STONE randomized clinical trial of Sonography and Testing of a Nephrolithiasis Episode. Emergencias. 2021 Feb;33(1):23-28. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the Point-of-Care Testing (POCT) and Point-of-Care ultrasound (POCUS) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First renal colic episode\n* Need of analgesia\n* Oral tolerance\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Fever\n* Anuria\n* Abdominal trauma\n* Chronic renal failure\n* Active oncologic disease\n* Kidney transplant or monorenal patient'}, 'identificationModule': {'nctId': 'NCT03706404', 'briefTitle': 'Renal Colic Fast Track Pathway in the Emergency Department.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz'}, 'officialTitle': 'Randomised Controlled Trial to Assess a Renal Colic Fast Track Pathway in the Emergency Department Using Point-of-care Ultrasound and Point-of-care Testing.', 'orgStudyIdInfo': {'id': 'URGG/HULP_2018_03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Point-of-care Testing and Ultrasound pathway', 'interventionNames': ['Diagnostic Test: Point-of-Care ultrasound and testing']}, {'type': 'NO_INTERVENTION', 'label': 'Classical pathway'}], 'interventions': [{'name': 'Point-of-Care ultrasound and testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-Care ultrasound + Point-of-Care blood gas testing', 'armGroupLabels': ['Point-of-care Testing and Ultrasound pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician, Fellow director of the ultrasound division in the emergency department, principal investigator.', 'investigatorFullName': 'Yale Tung Chen', 'investigatorAffiliation': 'Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz'}}}}