Central Line-associated Bloodstream Infection (CLABSI)NCT05919966
The Association Between Chlorhexidine Bathing and Central Line-Associated Infections in Medical Intensive Care Units
An observational study of Central Line-associated Bloodstream Infection (CLABSI), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI)
- What is being tested?
- Chlorhexidine bathing
- How many people
- 6,930 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2023to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all patients who were admitted to the MICU between January 2017 and June 2022
Who cannot join
- patients aged under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Chlorhexidine bathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine bathingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chlorhexidine bathing | |
| usual care group | Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays. |
What is being measured
The primary outcome is the main question the study is designed to answer.
central line-associated bloodstream infections
the incidence rate of intensive care unit acquired central line-associated bloodstream infections
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
multidrug-resistant organisms bacteremia
the incidence of CLABSIs with blood cultures positive for multidrug-resistant organisms
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Secondary outcomes (4)
ICU length of stay
the total duration of the patient's ICU stay (days)
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
hospital length of stay
the total duration of the patient's hospital stay (days)
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
ICU mortality
whether the patient has died during their stay in the ICU
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
hospital mortality
whether the patient has died during their stay in the hospital
Measured: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start12 Apr 2023
- Primary completion30 Apr 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chen Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919966
- Sponsor's protocol ID
- 202302031RINC
- Status last verified
- Apr 2023
- First submitted
- 13 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Chlorhexidine Bathing Every Other Day and Central Line-Associated Infections in Medical Intensive Care Units: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05919966
- Acronym / sponsor ID
- 202302031RINC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,930 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine group | – | Other: Chlorhexidine bathingPatients 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. |
| usual care group | – | –Patients were bathed with towels soaked in water and soap on a daily basis during the MICU stays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients who were admitted to the MICU between January 2017 and June 2022
Key exclusion criteria (1 listed)
- patients aged under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine bathingThe 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. | Other | chlorhexidine group |
Primary outcome
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
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
4 secondary outcomes
ICU length of stay
Time frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
hospital length of stay
Time frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
ICU mortality
Time frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
hospital mortality
Time frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chen Lin principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Line-associated Bloodstream Infection (CLABSI), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central line-associated bloodstream infections (time frame: Will be surveyed retrospectively through the study period (January 2017 to June 2022)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.