Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT05919966
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6930}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-25', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'central line-associated bloodstream infections', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': 'the incidence rate of intensive care unit acquired central line-associated bloodstream infections'}, {'measure': 'multidrug-resistant organisms bacteremia', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': 'the incidence of CLABSIs with blood cultures positive for multidrug-resistant organisms'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': "the total duration of the patient's ICU stay (days)"}, {'measure': 'hospital length of stay', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': "the total duration of the patient's hospital stay (days)"}, {'measure': 'ICU mortality', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': 'whether the patient has died during their stay in the ICU'}, {'measure': 'hospital mortality', 'timeFrame': 'Will be surveyed retrospectively through the study period (January 2017 to June 2022)', 'description': 'whether the patient has died during their stay in the hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Line-associated Bloodstream Infection (CLABSI)']}, 'descriptionModule': {'briefSummary': 'We conducted a retrospective observational cohort study assessing the relationship between regular bathing using 2% CHG wipes every other day and the occurrence of central line-associated infections (CLABSI) in patients within the medical intensive care unit (MICU).', 'detailedDescription': 'This study defined the post-intervention period as July 1, 2017, to June 30, 2022. During this period, one of the three medical intensive care units (MICUs) in NTUH implemented chlorhexidine gluconate (CHG) bathing as part of their daily care routine (CHG group). This decision was made in response to a higher incidence rate of vancomycin-resistant Enterococcus (VRE) bacteremia observed in that particular MICU during the preceding six months (pre-intervention period: January 1, 2017, to June 30, 2017), compared to the other two MICUs. The remaining two MICUs continued to provide usual care, which involved bathing patients with towels soaked in water and soap on a daily basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Our study included all patients aged eighteen years and older who were admitted to the MICU between January 2017 and June 2022, without any exclusions based on specific disease characteristics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients who were admitted to the MICU between January 2017 and June 2022\n\nExclusion Criteria:\n\n* patients aged under 18 years old'}, 'identificationModule': {'nctId': 'NCT05919966', 'briefTitle': 'The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Association Between Chlorhexidine Bathing Every Other Day and Central Line-Associated Infections in Medical Intensive Care Units: An Observational Cohort Study', 'orgStudyIdInfo': {'id': '202302031RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chlorhexidine group', 'description': 'Patients were bathed one day involving the use of wipes soaked in a 2% chlorhexidine gluconate (CHG) solution and the next day using a towel soaked with water and soap during the MICU stays.', 'interventionNames': ['Other: Chlorhexidine bathing']}, {'label': 'usual care group', 'description': 'Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays.'}], 'interventions': [{'name': 'Chlorhexidine bathing', 'type': 'OTHER', 'description': 'The procedure involved pouring an entire bottle (200ml) of 2% CHG solution (PBF Biotech, Taipei, Taiwan) onto a pre-packed set of eight single-use cotton wipes before each bathing session. A minimum of six wipes were required to thoroughly cover the entire body, including the bilateral upper and lower extremities, front and back of the trunk, perineum, and buttocks.', 'armGroupLabels': ['chlorhexidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Chen Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}