- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05919966
The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units
June 25, 2023 updated by: National Taiwan University Hospital
The Association Between Chlorhexidine Bathing Every Other Day and Central Line-Associated Infections in Medical Intensive Care Units: An Observational Cohort Study
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).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
6930
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- all patients who were admitted to the MICU between January 2017 and June 2022
Exclusion Criteria:
- patients aged under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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chlorhexidine group
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.
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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.
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usual care group
Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
central line-associated bloodstream infections
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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the incidence rate of intensive care unit acquired central line-associated bloodstream infections
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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multidrug-resistant organisms bacteremia
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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the incidence of CLABSIs with blood cultures positive for multidrug-resistant organisms
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU length of stay
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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the total duration of the patient's ICU stay (days)
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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hospital length of stay
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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the total duration of the patient's hospital stay (days)
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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ICU mortality
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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whether the patient has died during their stay in the ICU
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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hospital mortality
Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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whether the patient has died during their stay in the hospital
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Will be surveyed retrospectively through the study period (January 2017 to June 2022)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yi-Chen Lin, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2023
Primary Completion (Actual)
April 30, 2023
Study Completion (Actual)
May 30, 2023
Study Registration Dates
First Submitted
June 13, 2023
First Submitted That Met QC Criteria
June 25, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202302031RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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