The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections

Istanbul Medeniyet University

Status: Enrolling

Conditions: Bloodstream Infection Due to Central Venous Catheter; Central Venous Catheter Related Bloodstream Infection; Catheter-Related Infections

Treatments: Other: clorhexidine gluconate bathing

Study type: Interventional

Funder types: Other

Identifiers

NCT05995080

0009-0009-3168-4445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

chlorhexidine bathing group

Experimental group

Description:

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.

Treatment:

Other: clorhexidine gluconate bathing

standart bathing group

No Intervention group

Description:

Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every 72 hours in our facility.