Bloodstream Infection Due to Central Venous CatheterNCT05995080
Chlorhexidine Bathing in Critically Ill Children
A study testing clorhexidine gluconate bathing in people with Bloodstream Infection Due to Central Venous Catheter and Central Line-associated Bloodstream Infections, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Central line-associated bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. The incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Bloodstream Infection Due to Central Venous Catheter, Central Line-associated Bloodstream Infections
- What is being tested?
- clorhexidine gluconate bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Interventional
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 2 months and 18 years who had a temporary central venous catheter
- Patients whose follow-up is continued for at least 48 hours with a central venous catheter
Who cannot join
- Patients younger than 2 months of age
- Patients with a intensive care unit stay shorter than 48 hours
- Immunosuppressive patients
- Patients with a history of allergic reaction to chlorhexidine
- Patients with skin lesions that interfere with skin cleansing with chlorhexidine
- Patients whose family did not give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Daily 2% Chlorhexidine Gluconate Bathing on Central Line-Associated Bloodstream Infections in Critically Ill Children: A Single-Center Randomized Controlled Trial
Central line-associated bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. The incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. Bathing with solutions containing chlorhexidine has been included in preventive strategies in recent years. Although some studies have shown that chlorhexidine bathing reduces the frequency of hospital-associated infections, there are important differences in management of practice and adherence to practice in different facilities. The majority of the studies conducted include adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for children over 2 months of age to prevent Central line-associated bloodstream infections. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing Central line-associated bloodstream infections in pediatric patients with temporary central venous catheters.
Read the detailed description
In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group. Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.
Patients in both groups with a central catheter for longer than 48 hours will be treated with a standard bath every day. In addition to the control group, patients in the study group will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups will be compared in terms of Central line-associated bloodstream infections and catheter colonization.
- Conditions
- Bloodstream Infection Due to Central Venous Catheter, Central Line-associated Bloodstream Infections
- Being tested
- clorhexidine gluconate bathing
- Keywords
- chlorhexidine gluconate, Central line-associated bloodstream infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clorhexidine gluconate bathingOther
Also called cathater care practices
daily skin cleansing with chlorhexidine gluconate
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine bathing group | Experimental | Patients aged between 2 months and 18 years with temporary central venous catheter in the pediatric intensive care unit were recruited. Patients younger than 2 months of age, patients with a catheter use of less than 48 hours, patients with a history of allergic reaction with chlorhexidine, patients with a skin condition that interferes with skin cleansing with chlorhexidine, and immunocompromised patients were excluded from the study. Participants of the study were randomized with a ratio of 1:1. In study group, standard bathing will be applied on the first day of insertion of the central venous catheter, and in addition to that it is planned to clean the skin of the patient daily with cleaning pads impregnated with 2% Chlorhexidine gluconate. Receives: Other: clorhexidine gluconate bathing |
| standart bathing group | No intervention | Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every day in our facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central line-associated bloodstream infection
The main objective of this research was to perform a randomized controlled trial to evaluate the difference between daily 2% CHG bathing and daily standard soap with water bathing concerning the occurrence of CLABSI in critically ill children in the PICU who had undergone CVC placement.
Measured: 2 years.
Secondary outcomes (1)
Microorganisms that cause catheter colonization in patients which applied standard bathing
The secondary aims were to assess the rate of catheter colonization in both groups and to identify the microorganisms responsible for CLABSI and catheter colonization in this pediatric population.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 May 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bloodstream Infection Due to Central Venous CatheterStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saime Hacer Ozdemir, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995080
- Sponsor's protocol ID
- 0009-0009-3168-4445
- Status last verified
- May 2025
- First submitted
- 12 Jul 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zerr DM, Milstone AM, Dvorak CC, Adler AL, Chen L, Villaluna D, Dang H, Qin X, Addetia A, Yu LC, Conway Keller M, Esbenshade AJ, August KJ, Fisher BT, Sung L. Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group. Cancer. 2021 Jan 1;127(1):56-66. doi: 10.1002/cncr.33271. Epub 2020 Oct 20.
PubMed 33079403Tien KL, Sheng WH, Shieh SC, Hung YP, Tien HF, Chen YH, Chien LJ, Wang JT, Fang CT, Chen YC. Chlorhexidine Bathing to Prevent Central Line-Associated Bloodstream Infections in Hematology Units: A Prospective, Controlled Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):556-563. doi: 10.1093/cid/ciz874.
PubMed 31504341
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily 2% Chlorhexidine Gluconate Bathing on Central Line-Associated Bloodstream Infections in Critically Ill Children: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05995080
- Acronym / sponsor ID
- 0009-0009-3168-4445
- Conditions
- Bloodstream Infection Due to Central Venous Catheter, Central Line-associated Bloodstream Infections
- Keywords
- chlorhexidine gluconate, Central line-associated bloodstream infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Aug 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.
Central line-associated bloodstream infections are associated with increased mortality, morbidity, and length of hospital stay. The incidence has decreased significantly with the strict implementation of preventive bundle cares and checklists in intensive care units. Bathing with solutions containing chlorhexidine has been included in preventive strategies in recent years. Although some studies have shown that chlorhexidine bathing reduces the frequency of hospital-associated infections, there are important differences in management of practice and adherence to practice in different facilities. The majority of the studies conducted include adult patients. According to the CDC guidelines, chlorhexidine bathing is recommended for children over 2 months of age to prevent Central line-associated bloodstream infections. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing Central line-associated bloodstream infections in pediatric patients with temporary central venous catheters.
Detailed description
In patients with a central catheter for longer than 48 hours, the diagnosis of bloodstream infection will be recorded as laboratory-confirmed bloodstream infections according to CDC diagnostic criteria. Microorganisms detected in cultures will be classified as gram-positive and gram-negative or fungal agents. Infection with the resistant microorganism will be compared with the control group. Catheter colonization; be defined as bacterial growth of more than 15 colonies in the semiquantitative culture or 1000 colonies in the quantitative culture of the catheter segment or hub without clinical symptoms.
Patients in both groups with a central catheter for longer than 48 hours will be treated with a standard bath every day. In addition to the control group, patients in the study group will be treated daily with 2% chlorhexidine gluconate, and the patients in these two groups will be compared in terms of Central line-associated bloodstream infections and catheter colonization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine bathing group | Experimental | Other: clorhexidine gluconate bathingPatients aged between 2 months and 18 years with temporary central venous catheter in the pediatric intensive care unit were recruited. Patients younger than 2 months of age, patients with a catheter use of less than 48 hours, patients with a history of allergic reaction with chlorhexidine, patients with a skin condition that interferes with skin cleansing with chlorhexidine, and immunocompromised patients were excluded from the study. Participants of the study were randomized with a ratio of 1:1. In study group, standard bathing will be applied on the first day of insertion of the central venous catheter, and in addition to that it is planned to clean the skin of the patient daily with cleaning pads impregnated with 2% Chlorhexidine gluconate. |
| standart bathing group | No intervention | –Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every day in our facility. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between the ages of 2 months and 18 years who had a temporary central venous catheter
- Patients whose follow-up is continued for at least 48 hours with a central venous catheter
Key exclusion criteria (6 listed)
- Patients younger than 2 months of age
- Patients with a intensive care unit stay shorter than 48 hours
- Immunosuppressive patients
- Patients with a history of allergic reaction to chlorhexidine
- Patients with skin lesions that interfere with skin cleansing with chlorhexidine
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 |
|---|---|---|
| clorhexidine gluconate bathingAlso: cathater care practicesdaily skin cleansing with chlorhexidine gluconate | Other | chlorhexidine bathing group |
Primary outcome
Central line-associated bloodstream infection
Time frame: 2 years.
The main objective of this research was to perform a randomized controlled trial to evaluate the difference between daily 2% CHG bathing and daily standard soap with water bathing concerning the occurrence of CLABSI in critically ill children in the PICU who had undergone CVC placement.
1 secondary outcome
Microorganisms that cause catheter colonization in patients which applied standard bathing
Time frame: 2 years.
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 16 Sep 2026.
- Results publication: PubMed 33079403Zerr DM, Milstone AM, Dvorak CC, Adler AL, Chen L, Villaluna D, Dang H, Qin X, Addetia A, Yu LC, Conway Keller M, Esbenshade AJ, August KJ, Fisher BT, Sung L. Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group. Cancer. 2021 Jan 1;127(1):56-66. doi: 10.1002/cncr.33271. Epub 2020 Oct 20.
- Results publication: PubMed 31504341Tien KL, Sheng WH, Shieh SC, Hung YP, Tien HF, Chen YH, Chien LJ, Wang JT, Fang CT, Chen YC. Chlorhexidine Bathing to Prevent Central Line-Associated Bloodstream Infections in Hematology Units: A Prospective, Controlled Cohort Study. Clin Infect Dis. 2020 Jul 27;71(3):556-563. doi: 10.1093/cid/ciz874.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clorhexidine gluconate bathing in people with Bloodstream Infection Due to Central Venous Catheter and Central Line-associated Bloodstream Infections, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 16 Sep 2026. 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 Turkey (Türkiye). 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 infection (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995080, which also lists 2 linked publications.
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 16 Sep 2026.