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

• ClinicalTrials.gov Identifier: NCT05995080
• Recruitment Status: Recruiting
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Sponsor: Istanbul Medeniyet University
• Information provided by (Responsible Party): Saime Hacer Ozdemir, Istanbul Medeniyet University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Central Venous Catheter Related Bloodstream Infection; Catheter-Related Infections; Bloodstream Infection Due to Central Venous Catheter	Other: clorhexidine gluconate bathing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Investigator)
• Masking 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
• Official Title: The Effectiveness of Chlorhexidine Gluconate Bathing on Prevention of Catheter-Related Bloodstream Infections in Pediatric Intensive Care Unit
• Actual Study Start Date: May 1, 2022
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: May 1, 2024

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Catheter-related blood stream infection rates [ Time Frame: 2 years. ]

   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. Catheter colonization rates [ Time Frame: 2 years. ]
   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.
3. Demographic features of participants [ Time Frame: 2 years. ]

   The investigators will be evaluating the features below:

   • Age of the patients (months)
   • Sex of patients
   • Weight of patients (kilograms)
   • Height of patiens (centimeters)
4. Comorbidities of participants [ Time Frame: 2 years. ]
   The investigators will be evaluating the comorbidities in each groups, in order to determine if any of these conditions would interfere with infection rates.
5. Catheter site of placement [ Time Frame: 2 years. ]
   It will be classified as; femoral, internal jugular, subclavian.
6. The duration of intensive care unit stay for each participants [ Time Frame: 2 years. ]
   It will be evaluated as days.
7. Duration of catheter usage [ Time Frame: 2 years. ]
   It will be evaluated as the total amount of time as days.
8. Number of catheter lumens [ Time Frame: 2 years. ]
   It will be evaluated wether it has 2 or 3 lumens.
9. Time when catheter is started the use [ Time Frame: 2 years. ]

   It will be noted that the time of intensive care hospitalization that catheter usage started.

   It will be evaluated as days.

10. Number of catheter dressing changes [ Time Frame: 2 years. ]
    It will be evaluated that the amount of planned or unplanned changes of catheter dressing.
11. Reason for the catheter removal [ Time Frame: 2 years. ]
    It will be classified as for example; infection, dysfunction, lack of need...
12. The reason of intensive care hospitalization for each participants [ Time Frame: 2 years. ]
    It will be evaluated that the primary reason that cause for patient to need for intensive care.
13. PRISM (pediatric risk of mortality) score of the participants [ Time Frame: 2 years. ]
    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.
14. Need for invasive mechanical ventilation support [ Time Frame: 2 years. ]
    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.
15. Need for hemodialysis catheter usage [ Time Frame: 2 years. ]
    It will be noted that wether the patient has hemodialysis catheter or not.
16. Presence of parenteral steroid use [ Time Frame: 2 years. ]
    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

Secondary Outcome Measures :

1. Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily. [ Time Frame: Through study completion, 2 years. ]

   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.

2. Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily. [ Time Frame: 2 years. ]

   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.

3. Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily. [ Time Frame: 2 years. ]
   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.
4. Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily. [ Time Frame: 2 years. ]
   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.
5. Rate of catheter-related bloodstream infection in patients who applied standard bathing [ Time Frame: 2 years ]

   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.

6. Rate of catheter colonizsation in patients who applied standard bathing [ Time Frame: 2 years ]

   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.

7. Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing [ Time Frame: 2 years. ]
   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.
8. Microorganisms that cause catheter colonization in patients which applied standard bathing [ Time Frame: 2 years. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

IMU; Recruiting

Istanbul, Kadıköy, Turkey, 34800

Contact: saime hacer özdemir +905303862364 ozdemirshacer@gmail.com

Sub-Investigator: muhterem duyu

Sponsors and Collaborators

Istanbul Medeniyet University

More Information

Publications of Results:

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.

• Responsible Party: Saime Hacer Ozdemir, Principle Investigator, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05995080
• Other Study ID Numbers: 0009-0009-3168-4445
• First Posted: August 16, 2023
• Last Update Posted: August 16, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Saime Hacer Ozdemir, Istanbul Medeniyet University:

chlorhexidine gluconate; catheter-related bloodstream infections

Additional relevant MeSH terms:

Infections; Communicable Diseases; Sepsis; Catheter-Related Infections; Disease Attributes; Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation