Effect of Daily 2% Chlorhexidine Gluconate Bathing on Central Line-Associated Bloodstream Infections in Critically Ill Children: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 247
- 试验地点
- 3
- 主要终点
- Catheter colonization rates
研究概览
简要总结
Central line-associated 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 Central line-associated bloodstream infections. The aim of this study is to investigate the effect of daily bathing with 2% chlorhexidine gluconate solution in preventing Central line-associated bloodstream infections in pediatric patients with temporary central venous catheters.
详细描述
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 day. 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 Central line-associated bloodstream infections and catheter colonization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Investigator)
盲法说明
The control and study groups were determined by applying randomization at a ratio of 1:1 to the patients which participated to the study.
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: clorhexidine gluconate bathing (Other)
standart bathing group
Patients who are included in the study but not intervention group will be treated with standard bathing, which applied in every day in our facility.
结局指标
主要结局
Catheter colonization rates
时间窗: 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.
Catheter-related blood stream infection rates
时间窗: 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.
The duration of intensive care unit stay for each participants
时间窗: 2 years.
It will be evaluated as days.
Time when catheter is started the use
时间窗: 2 years.
It will be noted that the time of intensive care hospitalization that catheter usage started. It will be evaluated as days.
Demographic features of participants
时间窗: 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)
Comorbidities of participants
时间窗: 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.
Number of catheter dressing changes
时间窗: 2 years.
It will be evaluated that the amount of planned or unplanned changes of catheter dressing.
Reason for the catheter removal
时间窗: 2 years.
It will be classified as for example; infection, dysfunction, lack of need...
Catheter site of placement
时间窗: 2 years.
It will be classified as; femoral, internal jugular, subclavian.
Number of catheter lumens
时间窗: 2 years.
It will be evaluated wether it has 2 or 3 lumens.
PRISM (pediatric risk of mortality) score of the participants
时间窗: 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.
Need for invasive mechanical ventilation support
时间窗: 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.
Need for hemodialysis catheter usage
时间窗: 2 years.
It will be noted that wether the patient has hemodialysis catheter or not.
Duration of catheter usage
时间窗: 2 years.
It will be evaluated as the total amount of time as days.
The reason of intensive care hospitalization for each participants
时间窗: 2 years.
It will be evaluated that the primary reason that cause for patient to need for intensive care.
Presence of parenteral steroid use
时间窗: 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
Central line-associated bloodstream infection
时间窗: 2 years.
The main objective of this research was to perform a randomized controlled trial to evaluate the difference between daily 2% CHG bathing and daily standard soap with water bathing concerning the occurrence of CLABSI in critically ill children in the PICU who had undergone CVC placement.
次要结局
- Rate of catheter colonization in patients bathing with 2% chlorhexidine gluconate daily.(2 years.)
- Rate of catheter-related bloodstream infection in patients bathing with 2% chlorhexidine gluconate daily.(Through study completion, 2 years.)
- Microorganisms that grown in cultures of catheter-related bloodstream infection in patients which applied standard bathing(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 colonizsation in patients who applied standard bathing(2 years)
- Rate of catheter-related bloodstream infection in patients who applied standard bathing(2 years)
- Microorganisms that cause catheter colonization in patients which applied standard bathing(2 years.)
研究者
Saime Hacer Ozdemir
Principle Investigator
Istanbul Medeniyet University