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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
clorhexidine gluconate bathing
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Central Venous Catheter Related Bloodstream Infection focused on measuring chlorhexidine gluconate, catheter-related bloodstream infections

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

chlorhexidine bathing group

standart bathing group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 12, 2023
Last Updated
August 12, 2023
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05995080
Brief Title
The Effectiveness of Chlorhexidine Gluconate on Prevention of Catheter-Related Bloodstream Infections
Official Title
The Effectiveness of Chlorhexidine Gluconate Bathing on Prevention of Catheter-Related Bloodstream Infections in Pediatric Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Venous Catheter Related Bloodstream Infection, Catheter-Related Infections, Bloodstream Infection Due to Central Venous Catheter
Keywords
chlorhexidine gluconate, catheter-related bloodstream infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chlorhexidine bathing group
Arm Type
Experimental
Arm Description
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.
Arm Title
standart bathing group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
clorhexidine gluconate bathing
Other Intervention Name(s)
cathater care practices
Intervention Description
daily skin cleansing with chlorhexidine gluconate
Primary Outcome Measure Information:
Title
Catheter-related blood stream infection rates
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.
Time Frame
2 years.
Title
Catheter colonization rates
Description
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.
Time Frame
2 years.
Title
Demographic features of participants
Description
The investigators will be evaluating the features below: Age of the patients (months) Sex of patients Weight of patients (kilograms) Height of patiens (centimeters)
Time Frame
2 years.
Title
Comorbidities of participants
Description
The investigators will be evaluating the comorbidities in each groups, in order to determine if any of these conditions would interfere with infection rates.
Time Frame
2 years.
Title
Catheter site of placement
Description
It will be classified as; femoral, internal jugular, subclavian.
Time Frame
2 years.
Title
The duration of intensive care unit stay for each participants
Description
It will be evaluated as days.
Time Frame
2 years.
Title
Duration of catheter usage
Description
It will be evaluated as the total amount of time as days.
Time Frame
2 years.
Title
Number of catheter lumens
Description
It will be evaluated wether it has 2 or 3 lumens.
Time Frame
2 years.
Title
Time when catheter is started the use
Description
It will be noted that the time of intensive care hospitalization that catheter usage started. It will be evaluated as days.
Time Frame
2 years.
Title
Number of catheter dressing changes
Description
It will be evaluated that the amount of planned or unplanned changes of catheter dressing.
Time Frame
2 years.
Title
Reason for the catheter removal
Description
It will be classified as for example; infection, dysfunction, lack of need...
Time Frame
2 years.
Title
The reason of intensive care hospitalization for each participants
Description
It will be evaluated that the primary reason that cause for patient to need for intensive care.
Time Frame
2 years.
Title
PRISM (pediatric risk of mortality) score of the participants
Description
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.
Time Frame
2 years.
Title
Need for invasive mechanical ventilation support
Description
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.
Time Frame
2 years.
Title
Need for hemodialysis catheter usage
Description
It will be noted that wether the patient has hemodialysis catheter or not.
Time Frame
2 years.
Title
Presence of parenteral steroid use
Description
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
Time Frame
2 years.
Secondary Outcome Measure Information:
Title
Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
Description
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.
Time Frame
Through study completion, 2 years.
Title
Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
Description
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.
Time Frame
2 years.
Title
Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.
Description
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.
Time Frame
2 years.
Title
Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.
Description
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.
Time Frame
2 years.
Title
Rate of catheter-related bloodstream infection in patients who applied standard bathing
Description
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.
Time Frame
2 years
Title
Rate of catheter colonizsation in patients who applied standard bathing
Description
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.
Time Frame
2 years
Title
Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing
Description
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.
Time Frame
2 years.
Title
Microorganisms that cause catheter colonization in patients which applied standard bathing
Description
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.
Time Frame
2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
IMU
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
saime hacer özdemir
Phone
+905303862364
Email
ozdemirshacer@gmail.com
First Name & Middle Initial & Last Name & Degree
muhterem duyu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33079403
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 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.
Results Reference
result
PubMed Identifier
31504341
Citation
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.
Results Reference
result

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

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