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

NCT05995080 | Unknown

• 1 other identifier: 0009-0009-3168-4445
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

chlorhexidine gluconate; catheter-related bloodstream infections

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (8)

• Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.

  Through study completion, 2 years.

• Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.

  2 years.

• Microorganisms that grown in cultures of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.

  2 years.

• Microorganisms that cause catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.

  2 years.

• Rate of catheter-related bloodstream infection in patients who applied standard bathing

  2 years

Study Arms (2)

chlorhexidine bathing group

EXPERIMENTAL

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

standart bathing group

NO INTERVENTION

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.

Interventions

clorhexidine gluconate bathing OTHER

daily skin cleansing with chlorhexidine gluconate

Also known as: cathater care practices

chlorhexidine bathing group

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

IMU

Istanbul, Kadıköy, 34800, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 33079403 RESULT

• 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.

  PMID: 31504341 RESULT

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 16, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)