Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT01563406
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hub Cleansing to Prevent Hub Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D019840', 'term': '2-Propanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhayden@rush.edu', 'phone': '3129428727', 'title': 'Mary Hayden, MD', 'organization': 'Rush University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Single MICU\n* Large number of eligible hubs not evaluated\n* Unbalanced hub collection among study arms\n* Studied hub contamination only; unable to collect catheter tips\n* Did not study central-line associated bloodstream infection itself'}}, 'adverseEventsModule': {'timeFrame': '15 months', 'eventGroups': [{'id': 'EG000', 'title': 'Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Central Venous Catheter Hubs With Internal Contamination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'units': 'Hubs', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol, 15 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.'}, {'id': 'OG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.'}, {'id': 'OG002', 'title': 'Alcohol, 5 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.'}, {'id': 'OG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 months', 'description': 'This will be a qualitative outcome. It will be reported as "yes" or "no" for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms.', 'unitOfMeasure': 'contaminated hubs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hubs', 'denomUnitsSelected': 'Participants', 'populationDescription': '140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.'}, {'type': 'SECONDARY', 'title': 'Number of Contaminated Central Venous Catheter Tips', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec'}, {'id': 'OG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec'}, {'id': 'OG002', 'title': 'Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.'}, {'id': 'OG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec'}], 'timeFrame': '10 months', 'description': 'This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.'}, {'type': 'SECONDARY', 'title': 'Median Number of Microbial Colony Forming Units Per Hub Interior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}, {'units': 'Hubs', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alcohol, 15 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.'}, {'id': 'OG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.'}, {'id': 'OG002', 'title': 'Alcohol, 5 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.'}, {'id': 'OG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': 'Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '40'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 months', 'description': 'This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.', 'unitOfMeasure': 'colony forming units (CFU) per hub', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Hubs', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec'}, {'id': 'FG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec'}, {'id': 'FG002', 'title': 'Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.'}, {'id': 'FG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '194 hubs', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': '102 hubs', 'groupId': 'FG001', 'numSubjects': '30'}, {'comment': '101 hubs', 'groupId': 'FG002', 'numSubjects': '30'}, {'comment': '112 hubs', 'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '194 hubs', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': '102 hubs', 'groupId': 'FG001', 'numSubjects': '30'}, {'comment': '101 hubs', 'groupId': 'FG002', 'numSubjects': '30'}, {'comment': '112 hubs', 'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.', 'preAssignmentDetails': 'Two separate wings of a 24-bed MICU were randomized to receive different intervention sequences. Wing A was assigned to a 15 sec scrub of 1) Alcohol; 2) chlorhexidine gluconate (CHG)+Alcohol; 3) Alcohol; and Wing B was assigned to a 5 sec scrub of 1) CHG+Alcohol; 2) Alcohol; 3) CHG+Alcohol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec'}, {'id': 'BG001', 'title': 'Chlorhexidine+Alcohol, 15 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec'}, {'id': 'BG002', 'title': 'Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.'}, {'id': 'BG003', 'title': 'Chlorhexidine+Alcohol, 5 Second Scrub', 'description': '\\- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '17', 'groupId': 'BG000'}, {'value': '61', 'spread': '12', 'groupId': 'BG001'}, {'value': '53', 'spread': '17', 'groupId': 'BG002'}, {'value': '59', 'spread': '17', 'groupId': 'BG003'}, {'value': '59', 'spread': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '9', 'groupId': 'BG000'}, {'value': '31', 'spread': '11', 'groupId': 'BG001'}, {'value': '30', 'spread': '14', 'groupId': 'BG002'}, {'value': '32', 'spread': '13', 'groupId': 'BG003'}, {'value': '30', 'spread': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mechanical ventilation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Decubitus ulcer', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diarrhea', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Heart disease', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pulmonary Disease', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Liver disease', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '135', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Central venous catheter (CVC) type', 'classes': [{'title': 'Triple lumen', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '351', 'groupId': 'BG004'}]}]}, {'title': 'PICC', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '158', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'hubs'}, {'title': 'Anatomic location of CVC', 'classes': [{'title': 'Internal/external jugular', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '295', 'groupId': 'BG004'}]}]}, {'title': 'Basilic/cephalic/brachial', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}, {'title': 'Femoral', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}, {'title': 'Subclavian', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'hubs'}, {'title': 'Time hub in place', 'classes': [{'categories': [{'measurements': [{'value': '95', 'spread': '27', 'groupId': 'BG000'}, {'value': '101', 'spread': '41', 'groupId': 'BG001'}, {'value': '100', 'spread': '33', 'groupId': 'BG002'}, {'value': '94', 'spread': '25', 'groupId': 'BG003'}, {'value': '97', 'spread': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'No. hubs per patient', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG004', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hubs per patient', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': '140 participants, 149 separate MICU admissions, 509 hubs total. Each MICU admission is treated as a separate enrollment.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2012-02-15', 'resultsFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-14', 'studyFirstPostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Central Venous Catheter Hubs With Internal Contamination', 'timeFrame': '15 months', 'description': 'This will be a qualitative outcome. It will be reported as "yes" or "no" for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms.'}], 'secondaryOutcomes': [{'measure': 'Number of Contaminated Central Venous Catheter Tips', 'timeFrame': '10 months', 'description': 'This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as "yes" or "no".'}, {'measure': 'Median Number of Microbial Colony Forming Units Per Hub Interior', 'timeFrame': '15 months', 'description': 'This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Needleless connectors', 'catheter hubs'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a superior disinfectant at the site of central venous catheter insertion. Scrub duration of central venous catheter hubs will also be evaluated.', 'detailedDescription': 'A prospective randomized blinded crossover clinical trial will be performed in the medical intensive care unit at Rush University Medical Center. The intensive care unit will be divided into two regions (A\\&B). Hub disinfectants and duration of disinfection will be randomly assigned to these regions. After 1/2 of the study period, the agents will crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters.\n\nIn February 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. It was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible.\n\n3/27/12-Internal hub contamination (yes/no)was clarified as the primary outcome.\n\nOn 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. The expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. This more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub.\n\nThe first crossover time selected was 6/11/12, prior to the midpoint of the study. This was done to try to improve a large imbalance in the group sizes.\n\nOn 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips.\n\nOn 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips.\n\nOn 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical intensive care unit patients with non-tunneled central venous catheters\n\nExclusion Criteria:\n\n* Dialysis catheters\n* Antibiotic-impregnated catheters\n* Introducer sheaths\n* Tunneled catheters'}, 'identificationModule': {'nctId': 'NCT01563406', 'acronym': 'HUC-PHIN', 'briefTitle': 'Hub Cleansing to Prevent Hub Infection', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Hub Cleansing to Prevent Hub Infection', 'orgStudyIdInfo': {'id': 'U54CK000161-01W1', 'link': 'https://reporter.nih.gov/quickSearch/U54CK000161-01W1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol with 5 second scrub', 'description': '70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.', 'interventionNames': ['Other: 5 second scrub', 'Drug: 70% isopropyl alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Alcohol with 15 second scrub', 'description': '70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.', 'interventionNames': ['Other: 15 second scrub', 'Drug: 70% isopropyl alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine with 5 second scrub', 'description': '3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 5 seconds.', 'interventionNames': ['Other: 5 second scrub', 'Drug: 3.15% chlorhexidine/70% isopropyl alcohol']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine with 15 second scrub', 'description': '3.15% chlorhexidine/70% isopropyl alcohol will be used to scrub catheter hubs for a duration of 15 seconds.', 'interventionNames': ['Other: 15 second scrub', 'Drug: 3.15% chlorhexidine/70% isopropyl alcohol']}], 'interventions': [{'name': '15 second scrub', 'type': 'OTHER', 'description': 'Scrub catheter hubs for 15 seconds before every access.', 'armGroupLabels': ['Alcohol with 15 second scrub', 'Chlorhexidine with 15 second scrub']}, {'name': '5 second scrub', 'type': 'OTHER', 'description': 'Scrub catheter hubs for 15 seconds before every access.', 'armGroupLabels': ['Alcohol with 5 second scrub', 'Chlorhexidine with 5 second scrub']}, {'name': '3.15% chlorhexidine/70% isopropyl alcohol', 'type': 'DRUG', 'otherNames': ['Professional Disposables International Inc. Chlorascrub Swab'], 'description': '3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.', 'armGroupLabels': ['Chlorhexidine with 15 second scrub', 'Chlorhexidine with 5 second scrub']}, {'name': '70% isopropyl alcohol', 'type': 'DRUG', 'otherNames': ['Professional Disposable International Inc Alcohol Prep Pad'], 'description': '70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.', 'armGroupLabels': ['Alcohol with 15 second scrub', 'Alcohol with 5 second scrub']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mary K Hayden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Robert A Weinstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cook County Health and Hospital Systems'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Rush University Medical Center adheres to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of NIH Grants and Contracts. Our response to requests for research resources from academic and other non-profit investigators will be timely and will be based on the Simple Letter Agreement for the Transfer of Materials as described in the Guidelines for Disseminating Research Resources Arising Out of NIH-Funded Research (Federal Register, Vol. 64, No 246, p.72094), and will not be more restrictive than the Uniform Biological Materials Transfer Agreement (UBMTA). Any intellectual property resulting from this study that can be patented will remain easily and widely available to the researchers in accordance with the NIH Principles and Guidelines. Distribution of resources to for-profit entities may occur under material transfer agreements or non-exclusive license arrangements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}