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

The Effectiveness of Chlorhexidine Gluconate Bathing on Prevention of Catheter-Related Bloodstream Infections in Pediatric Intensive Care Unit

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.

Study Overview

• Status: Recruiting
• Conditions: Catheter-Related Infections; Central Venous Catheter Related Bloodstream Infection; Bloodstream Infection Due to Central Venous Catheter
• Intervention / Treatment: Other: clorhexidine gluconate bathing

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kadıköy
    • Istanbul, Kadıköy, Turkey, 34800
      • Recruiting
      • IMU
      • Contact: saime hacer özdemir; Phone Number: +905303862364; Email: ozdemirshacer@gmail.com
      • Sub-Investigator: muhterem duyu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: clorhexidine gluconate bathing; daily skin cleansing with chlorhexidine gluconate; Other Names: cathater care practices
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter-related blood stream infection rates	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.	2 years.
Catheter colonization rates	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.	2 years.
Demographic features of participants	The investigators will be evaluating the features below: Age of the patients (months); Sex of patients; Weight of patients (kilograms); Height of patiens (centimeters)	2 years.
Comorbidities of participants	The investigators will be evaluating the comorbidities in each groups, in order to determine if any of these conditions would interfere with infection rates.	2 years.
Catheter site of placement	It will be classified as; femoral, internal jugular, subclavian.	2 years.
The duration of intensive care unit stay for each participants	It will be evaluated as days.	2 years.
Duration of catheter usage	It will be evaluated as the total amount of time as days.	2 years.
Number of catheter lumens	It will be evaluated wether it has 2 or 3 lumens.	2 years.
Time when catheter is started the use	It will be noted that the time of intensive care hospitalization that catheter usage started. It will be evaluated as days.	2 years.
Number of catheter dressing changes	It will be evaluated that the amount of planned or unplanned changes of catheter dressing.	2 years.
Reason for the catheter removal	It will be classified as for example; infection, dysfunction, lack of need...	2 years.
The reason of intensive care hospitalization for each participants	It will be evaluated that the primary reason that cause for patient to need for intensive care.	2 years.
PRISM (pediatric risk of mortality) score of the participants	The Pediatric Risk of Mortality (PRISM) score was developed from the Physiologic Stability Index (PSI) to reduce the number of physiologic variables required for pediatric ICU (PICU) mortality risk assessment and to obtain an objective weighting of the remaining variables.	2 years.
Need for invasive mechanical ventilation support	It will be evaluated if the patient needed for invasive mechanical ventilation support or not. If so, how many days is it required will be noted.	2 years.
Need for hemodialysis catheter usage	It will be noted that wether the patient has hemodialysis catheter or not.	2 years.
Presence of parenteral steroid use	It will be noted that if during the intensive unit care, wether patient need pulse steroid treatment (30milligram/kilogram/day for 3 or more days) or treatment with Prednisolone 2 milligram/kilogram/day or more for 14 or more days	2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.	Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infections in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine. Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.	Through study completion, 2 years.
Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.	Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent daily skin cleansing with chlorhexidine, compared to the total number of patients who underwent daily skin cleansing with chlorhexidine. Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.	2 years.
Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.	It will be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.	2 years.
Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.	It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.	2 years.
Rate of catheter-related bloodstream infection in patients who applied standard bathing	Incidence will be determined by dividing the number of patients who had catheter-related bloodstream infection in patients who underwent standard bathing to the total number of patients who underwent standard bathing. Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.	2 years
Rate of catheter colonizsation in patients who applied standard bathing	Incidence will be determined by dividing the number of patients who had catheter colonization in patients who underwent standard bathing to the total number of patients who underwent standard bathing. Patients who were treated with a standard bath and those treated with a chlorhexidine bath will be compared.	2 years
Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing	It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.	2 years.
Microorganisms that cause catheter colonization in patients which applied standard bathing	It will also be noted which microorganisms grown in the cultures. By classifying microorganisms grown in culture (gram positive, gram negative, fungal infections, etc.), a comparison will be made between the two groups in terms of incidence.	2 years.

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: chlorhexidine gluconate; catheter-related bloodstream infections
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases; Catheter-Related Infections
• Other Study ID Numbers: 0009-0009-3168-4445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No