Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT00847392
Status:
WITHDRAWN
Last Update Posted:
2016-09-19
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine Pediatric Bladder Volume Prior to Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Inability to obtain grant funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.', 'timeFrame': 'First feasible attempt at catheterization during ED visit (minutes-hours).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urethral catheterization', 'Emergency Department', 'Ultrasound', 'Urinary tract infection', 'Pediatric'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.\n\nUltrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 0-36 months of age\n* Require urethral catheterization for urine analysis\n\nExclusion Criteria:\n\n* Recently voided and unlikely to provide sufficient urine when catheterized\n* Documented or suspected genitourinary abnormalities precluding urethral catheterization\n* Indwelling catheter or urostomy\n* Critical illness\n* No available legal guardian or legal guardian does not understand English well enough to provide informed consent\n* Technical failure of the utlrasound equipment'}, 'identificationModule': {'nctId': 'NCT00847392', 'acronym': 'PV-BUS', 'briefTitle': 'Study to Determine Pediatric Bladder Volume Prior to Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Pediatric Volumetric Bladder Ultrasound Study', 'orgStudyIdInfo': {'id': 'PV-BUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound', 'description': 'Bladder ultrasound prior to catheterization', 'interventionNames': ['Procedure: Ultrasound prior to bladder catheterization']}, {'type': 'NO_INTERVENTION', 'label': 'Standard catheterization', 'description': 'No ultrasound prior to bladder catheterization'}], 'interventions': [{'name': 'Ultrasound prior to bladder catheterization', 'type': 'PROCEDURE', 'description': 'Bedside ultrasound to estimated volume of urine in bladder', 'armGroupLabels': ['Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5G4T8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Andrew Worster, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Andrew Worster', 'oldOrganization': 'Hamilton Health Sciences'}}}}