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

NCT ID: NCT05995080

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

chlorhexidine bathing group

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.

Group Type: EXPERIMENTAL

clorhexidine gluconate bathing

Intervention Type: OTHER

daily skin cleansing with chlorhexidine gluconate

standart bathing group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

clorhexidine gluconate bathing

daily skin cleansing with chlorhexidine gluconate

Intervention Type: OTHER

Other Intervention Names

cathater care practices

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Saime Hacer Ozdemir

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IMU

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

saime hacer özdemir

Role: primary

ozdemirshacer@gmail.com

+905303862364

References

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.

Reference Type: RESULT

PMID: 33079403 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31504341 (View on PubMed)

Other Identifiers

0009-0009-3168-4445

Identifier Type: -

Identifier Source: org_study_id