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

Last updated: August 12, 2023
Sponsor: Istanbul Medeniyet University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Catheter Complications

Soft Tissue Infections

Treatment

clorhexidine gluconate bathing

Clinical Study ID

NCT05995080
0009-0009-3168-4445
  • Ages 2-18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients between the ages of 2 months and 18 years who had a temporary central venouscatheter
  • Patients whose follow-up is continued for at least 48 hours with a central venouscatheter

Exclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: clorhexidine gluconate bathing
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
May 01, 2024

Study 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.

Connect with a study center

  • IMU

    Istanbul, Kadıköy 34800
    Turkey

    Active - Recruiting

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