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

Catheter-Related Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995080
• Other study ID #: 0009-0009-3168-4445
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: August 2023
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection Due to Central Venous Catheter
• Catheter-Related Infections
• Central Venous Catheter Related Bloodstream Infection
• Communicable Diseases
• Infections
• Sepsis

Intervention

Other:
• clorhexidine gluconate bathing
daily skin cleansing with chlorhexidine gluconate

Locations

Country	Name	City	State
Turkey	IMU	Istanbul	Kadiköy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 — View Citation

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Catheter site of placement	It will be classified as; femoral, internal jugular, subclavian.	2 years.
Primary	The duration of intensive care unit stay for each participants	It will be evaluated as days.	2 years.
Primary	Duration of catheter usage	It will be evaluated as the total amount of time as days.	2 years.
Primary	Number of catheter lumens	It will be evaluated wether it has 2 or 3 lumens.	2 years.
Primary	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.
Primary	Number of catheter dressing changes	It will be evaluated that the amount of planned or unplanned changes of catheter dressing.	2 years.
Primary	Reason for the catheter removal	It will be classified as for example; infection, dysfunction, lack of need...	2 years.
Primary	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.
Primary	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.
Primary	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.
Primary	Need for hemodialysis catheter usage	It will be noted that wether the patient has hemodialysis catheter or not.	2 years.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.