Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT00485992
Status:
TERMINATED
Last Update Posted:
2011-11-21
First Post:
2007-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chlorhexidine Swabs Effectiveness in Reducing Blood Stream Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'whyStopped': 'sufficient data has been collected for significant conclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2007-06-12', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['blood stream infection', 'CICU', 'pediatric', 'chlorhexidine swabs'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'Children\'s Healthcare of Atlanta (Children\'s) is collaborating with Child Health Corporation of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections (BSIs). "As well as the human cost, central venous catheter related bloodstream infections significantly inflate hospital costs, mainly through increased length of stay in hospital, particularly in intensive care" (Jones, 2006).\n\nThe Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing the BSI "Bundles" per the CHCA guidelines. BSI "bundles" are a group of patient care practices designed to reduce BSI infection rates with implementation in patient care areas. The bundles include recommendations for central line maintenance including line insertion, dressing changes, line accesses, and monitoring for medical necessity. These bundles were implemented on January 16, 2006, when the BSI rate in the CICU had peaked at 18.2 (rate of infections per 1000 catheter days). The BSI rates historically for the past two years have been highly variable (see attached graph for data from Jan. 04 through Oct. 06). The target goal is to maintain a rate below 3.7 which has only been realized twice since the January BSI bundle implementation.\n\nCurrent practice for the care of central lines outlined in the BSI Bundles is based on the Centers for Disease Control and Prevention (CDC) guidelines published in 2002. These guidelines included important changes to practice involving the use of chlorhexidine (CHG) containing products for improved infection prevention. CHG solutions are currently available as either 2% or 3.15% chlorhexidine gluconate in a 70% isopropyl alcohol solution.\n\nThe Primary Aim is to determine if CHG is effective as an antiseptic wipe for accessing lines to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice for the CICU.', 'detailedDescription': 'Children\'s Healthcare of Atlanta (Children\'s) is collaborating with Child Health Corporation of America (CHCA) in the nationwide effort to reduce catheter related blood stream infections (BSIs).\n\nThe Cardiac Intensive Care Unit (CICU) is participating in this initiative by implementing the BSI "Bundles" per the CHCA guidelines. BSI "bundles" are a group of patient care practices designed to reduce BSI infection rates with implementation in patient care areas.\n\nMultiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population.\n\nMany risk factors cannot be controlled, such as patient age, weight, diagnosis, etc. Hence the controllable risk factors are the focus for reducing BSI rates, primarily related to the care of central lines. This is the main focus of the BSI Bundles which are aimed at reducing the risks associated with the utilization of central lines.\n\nThe primary aim is to determine if CHG is effective as an antiseptic wipe for accessing lines to draw blood and administer medications. Compare the effectiveness of CHG containing alcohol wipes (3.15% CHG/70% isopropyl alcohol) to plain alcohol in order to determine best practice for the CICU.\n\nThe secondary aim is to reduce BSI rates in the CICU patient population, improving patient care outcomes and reducing costs of hospitalization by the resulting reduction and prevention of expected BSIs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This study will observe from all children admitted to Children's CICU between 8.1.06 to 12.31.06; including both medical and surgical service patients.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients in Children's Healthcare of Atlanta, Egleston, in CICU between 8.1.06 to 12.31.06\n\nExclusion Criteria:\n\n* those who do not qualify under inclusion criteria."}, 'identificationModule': {'nctId': 'NCT00485992', 'briefTitle': 'Chlorhexidine Swabs Effectiveness in Reducing Blood Stream Infections', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Effectiveness of Utilizing Chlorhexidine Swabs for Accessing Lines and Results Impact on Catheter Related Blood Stream Infections in the Cardiac Intensive Care Unit', 'orgStudyIdInfo': {'id': '06-201'}}, 'contactsLocationsModule': {'locations': [{'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Nicole M Jarrell, RNC, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Director Research', 'oldOrganization': "Children's Healthcare of Atlanta Institutional Review Board"}}}}