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The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units

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ClinicalTrials.gov Identifier: NCT05919966
Recruitment Status : Completed
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Central Line-associated Bloodstream Infection (CLABSI) Other: Chlorhexidine bathing

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 Design
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Study Type : Observational
Actual Enrollment : 6930 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Association Between Chlorhexidine Bathing Every Other Day and Central Line-Associated Infections in Medical Intensive Care Units: An Observational Cohort Study
Actual Study Start Date : April 12, 2023
Actual Primary Completion Date : April 30, 2023
Actual Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Chlorhexidine bathing
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.
usual care group
Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays.


Outcome Measures
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Primary Outcome Measures :
  1. central line-associated bloodstream infections [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    the incidence rate of intensive care unit acquired central line-associated bloodstream infections

  2. multidrug-resistant organisms bacteremia [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    the incidence of CLABSIs with blood cultures positive for multidrug-resistant organisms


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    the total duration of the patient's ICU stay (days)

  2. hospital length of stay [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    the total duration of the patient's hospital stay (days)

  3. ICU mortality [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    whether the patient has died during their stay in the ICU

  4. hospital mortality [ Time Frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022) ]
    whether the patient has died during their stay in the hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • all patients who were admitted to the MICU between January 2017 and June 2022

Exclusion Criteria:

  • patients aged under 18 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919966


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yi-Chen Lin National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT05919966    
Other Study ID Numbers: 202302031RINC
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Sepsis
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
 Inflammation
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants