Clinical trial NCT05995080: The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections
Official title: The Effectiveness of Chlorhexidine Gluconate Bathing on Prevention of Catheter-Related Bloodstream Infections in Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Venous Catheter Related Bloodstream Infection
Catheter-Related Infections
Bloodstream Infection Due to Central Venous Catheter
Keywords: chlorhexidine gluconate
catheter-related bloodstream infections
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: Catheter-related 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 catheter-related bloodstream infection. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing catheter-related 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 72 hours. 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 catheter-related bloodstream infections and catheter colonization.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Catheter-related blood stream infection rates
timeFrame: 2 years.
measure: Catheter colonization rates
timeFrame: 2 years.
measure: Demographic features of participants
timeFrame: 2 years.
measure: Comorbidities of participants
timeFrame: 2 years.
measure: Catheter site of placement
timeFrame: 2 years.
measure: The duration of intensive care unit stay for each participants
timeFrame: 2 years.
measure: Duration of catheter usage
timeFrame: 2 years.
measure: Number of catheter lumens
timeFrame: 2 years.
measure: Time when catheter is started the use
timeFrame: 2 years.
measure: Number of catheter dressing changes
timeFrame: 2 years.
measure: Reason for the catheter removal
timeFrame: 2 years.
measure: The reason of intensive care hospitalization for each participants
timeFrame: 2 years.
measure: PRISM (pediatric risk of mortality) score of the participants
timeFrame: 2 years.
measure: Need for invasive mechanical ventilation support
timeFrame: 2 years.
measure: Need for hemodialysis catheter usage
timeFrame: 2 years.
measure: Presence of parenteral steroid use
timeFrame: 2 years.
Secondary outcomes:
measure: Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
timeFrame: Through study completion, 2 years.
measure: Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
timeFrame: 2 years.
measure: Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
timeFrame: 2 years.
measure: Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
timeFrame: 2 years.
measure: Rate of catheter-related bloodstream infection in patients who applied standard bathing
timeFrame: 2 years
measure: Rate of catheter colonizsation in patients who applied standard bathing
timeFrame: 2 years
measure: Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing
timeFrame: 2 years.
measure: Microorganisms that cause catheter colonization in patients which applied standard bathing
timeFrame: 2 years.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: IMU
state: Kadıköy
Study officials:
References:
citation: 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.
citation: Tien 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.