Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-01 @ 12:06 AM
Study NCT ID:
NCT00672503
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2008-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-07', 'studyFirstSubmitDate': '2008-05-02', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of risk factors associated with indwelling urinary catheters.', 'timeFrame': '2004-2007'}], 'secondaryOutcomes': [{'measure': "Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters.", 'timeFrame': '2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['indwelling urinary catheters', 'urinary tract infections', 'foley-catheter related infections', 'hospital acquired CA-UTI'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to identify risk factors associated with indwelling urinary catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The study will also include a very extensive literature search in an attempt to create a national standard or guideline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "1. Patients who acquired a CA-UTI while hospitalized in the PICU between 2004-2007.\n2. Patients who had an indwelling urinary catheter while hospitalized in the PICU between 2004-2007 but did not acquire a CA-UTI.\n3. Nurses currently employed in the PICU at Children's Mercy Hospital.\n4. All Patient's who acquired a CA-UTI during 2009", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Medical records of 67 patients 0 to 17 years of age diagnosed with a catheter associated urinary tract infection (defined by CDC) acquired during a PICU hospitalization.\n2. Medical records of 67 patients 0 to 17 years of age who had an indwelling urinary catheter during a PICU hospitalization without a catheter associated urinary tract infection.\n3. Nurses employed at Children's Mercy Hospital in the PICU.\n4. Patient's who acquired a CA-UTI during 2009 and was adjudicated by infection control.\n\nExclusion Criteria:\n\nPatients\n\n1. Patients with community acquired urinary tract infections\n2. Patients 18 years and older cared for in the PICU.\n3. Patients with catheter associated urinary tract infections hospitalized outside the PICU at Children's Mercy Hospital.\n4. Patients with UTI not related to catheterization\n\nNurses\n\n1. Nurses floated to the PICU who are not permanent staff members (ICN nurse, float pool staff, travelers)\n2. Nurses on the research team"}, 'identificationModule': {'nctId': 'NCT00672503', 'briefTitle': 'Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': '"Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': '08 04-065E'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients who acquired a CA-UTI in the PICU between 2004-2007.'}, {'label': '2', 'description': 'Patients who did not acquire a CA-UTI while hospitalized in the PICU but had an indwelling urinary catheter between 2004-2007.'}, {'label': 'A', 'description': "Nurses currently employed in the PICU at Children's Mercy Hospital."}, {'label': 'a', 'description': 'Root Cause Analysis on all patients who acquired a CA-UTI during 2009.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Tangela M Welch, ADN, BBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Mercy Hospital Kansas City"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PICU Clinical Research Coordinator', 'investigatorFullName': 'Tangela Welch', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}