Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-01 @ 10:03 PM
Study NCT ID:
NCT01067768
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2010-02-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mrestrepo@hptu.org.co', 'phone': '57-4-4459315', 'title': 'Dr. María Victoria Restrepo', 'organization': 'Hospital Pablo Tobón Uribe'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Daily Review', 'description': 'In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.', 'otherNumAtRisk': 604, 'otherNumAffected': 0, 'seriousNumAtRisk': 604, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.', 'otherNumAtRisk': 605, 'otherNumAffected': 0, 'seriousNumAtRisk': 605, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Catheter-associated Urinary Tract Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Review', 'description': 'Daily monitoring of catheter indication'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '6.58', 'upperLimit': '14.02'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8.85', 'upperLimit': '16.34'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.3', 'estimateComment': 'The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.', 'groupDescription': 'The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)', 'unitOfMeasure': 'infections per 1000 days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis by intention to treat'}, {'type': 'SECONDARY', 'title': 'Catheter Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daily Review', 'description': 'Daily monitoring of catheter indication'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05', 'groupDescription': 'Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'withdrawal of the catheter', 'description': 'The duration of catheterization', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis by intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daily Review', 'description': 'In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}, {'groupId': 'FG001', 'numSubjects': '605'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}, {'groupId': 'FG001', 'numSubjects': '605'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult patients hospitalized with indwelling urinary catheters at a tertiary care, 300-bed, teaching hospital in Colombia- South America, were recruitment between November 2009 and May 2010.', 'preAssignmentDetails': '1.325 patients were assessed for eligibility. 143 were excluded (98 urinary infection and 45 spinal cord injury).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '604', 'groupId': 'BG000'}, {'value': '605', 'groupId': 'BG001'}, {'value': '1209', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily Review', 'description': 'In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '69'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '37', 'upperLimit': '69'}, {'value': '55.5', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '354', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '706', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '521', 'groupId': 'BG001'}, {'value': '1037', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Diabetes mellitus registered as a personal history or diagnosed on admission', 'unitOfMeasure': 'participants'}, {'title': 'Kidney failure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '500', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Creatinine greater than 2 mg/dL at any time during hospitalization', 'unitOfMeasure': 'participants'}, {'title': 'Indication of catheter', 'classes': [{'title': 'Obstruction', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Incontinence', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Monitoring', 'categories': [{'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '537', 'groupId': 'BG002'}]}]}, {'title': 'Procedures', 'categories': [{'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '619', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Unit placement', 'classes': [{'title': 'Emergency', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}, {'title': 'Critical care', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Surgery', 'categories': [{'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}]}, {'title': 'General room', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Before admission', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Another', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Site of insertion of the catheter', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2010-02-10', 'resultsFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-11', 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Catheter-associated Urinary Tract Infection', 'timeFrame': 'Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)'}], 'secondaryOutcomes': [{'measure': 'Catheter Days', 'timeFrame': 'withdrawal of the catheter', 'description': 'The duration of catheterization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary Tract Infections', 'Catheter-associated urinary tract infections', 'Prevention and control', 'Controlled clinical trial'], 'conditions': ['Urinary Tract Infections', 'Urinary Tract; Accessory']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the daily nurse review of the indication of the urinary catheter compared to the everyday care of the working staff is effective to reduce the rate of catheter-associated urinary tract infection in adults hospitalized.', 'detailedDescription': 'Healthcare-associated infection (HAI)in hospitalized patients are very frequent, especially the catheter-associated urinary tract infection, which prolongs the hospital stay and costs, and is about 3 times more likely to die during hospitalization than patients not infected.\n\nThe measures of aseptic insertion and closed systems of collection, as well as the rational use of the probe reduce the risk for infection.\n\nA checklist that contains the agreed indications of catheter, related to obstruction, incontinence, skin lesions in sacral region, monitoring or surgical procedures allows the daily review of the indication of the probe. If the patient doesn´t meet at least one of the criteria, should be recommended the withdrawal of the catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient with a permanent urinary catheter (balloon catheter)\n* Urinary catheter placed in the hospitalization (previous day) or at admission\n\nExclusion Criteria:\n\n* Urinary tract infection diagnosis at time of the insertion\n* Spinal cord injury or neurogenic bladder at admission'}, 'identificationModule': {'nctId': 'NCT01067768', 'briefTitle': 'Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Pablo Tobón Uribe'}, 'officialTitle': 'Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5100-66592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily review', 'description': 'In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.', 'interventionNames': ['Other: Daily review']}, {'type': 'NO_INTERVENTION', 'label': 'Routine care', 'description': 'In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.'}], 'interventions': [{'name': 'Daily review', 'type': 'OTHER', 'otherNames': ['Review for indication'], 'description': 'Daily nursing review of the urinary catheter´s indication. If the patient meets at least one of the entries to stay with bladder catheter, the nurse will record collection in the format but will not contact the health team. If there aren´t indication in the medical record, she contacts at the attending physician and said: "Doctor, I didn´t find record in the history of the indication of the urinary catheter, can we withdraw?. If the physician reported the indication, will be recorded in the format without additional comments.\n\nThe attending physician decides withdraw or no withdraw the urinary catheter', 'armGroupLabels': ['Daily review']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'María V Restrepo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Pablo Tobón Uribe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Pablo Tobón Uribe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MSc', 'investigatorFullName': 'Maria Victoria Restrepo', 'investigatorAffiliation': 'Hospital Pablo Tobón Uribe'}}}}