Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
研究概览
简要总结
Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. The purpose of this study is to evaluate the effects of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term central venous catheters in pediatric patients.
详细描述
The patients was divided into two groups, where one received alcoholization (ethanol lock therapy group) and the other not (control group). The variables evaluated were: CLABSI, etiological agents, adverse events and the mechanical effects of ethanol on the catheter (breakage and obstruction). To determine the association between the independent variable and the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95% confidence interval (95% CI). The significance level of 5% was adopted. The sample size calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter clinical trial was used to calculate the sample size, which demonstrated a 9% central venous catheter infection frequency in the ethanol group and 37% in the control group, so that the sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of 5% and 10% of post-randomization losses.
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
- Single (Outcomes Assessor)
盲法说明
Following inclusion, the patients were randomized into two groups, the ethanol-lock group and the control group, using allocation concealment with a list of random numbers generated using the Random Allocation Software
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric surgery patients;
- •Weight: 2 Kg or more;
- •Using non-tunneled double-lumen polyurethane central venous catheter;
- •CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU);
- •CVC adequately positioned (checked by radioscopy ou radiography);
- •CVC implanted within a maximum of 24 hours.
排除标准
- •Patients whose catheters had been inserted under emergency situations;
- •Patients in a critical condition (those requiring continuous fluid/drug infusion through both lumens);
- •Patients with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study.
研究组 & 干预措施
Ethanol-lock therapy (ELT) Group
This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters
干预措施: Ethanol-lock (Drug)
结局指标
主要结局
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
时间窗: Period from 48 hours after catheter insertion to 24 hours after catheter removal
Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.
次要结局
- main etiological agents involved in central line associated bloodstream infection (CLABSI) events(Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.)
- Incidence of Treatment-Emergent Adverse Events(During the use of ethanol-lock therapy)
- Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)(During the use of ethanol-lock therapy)
研究者
Flavia orange
PhD
Instituto Materno Infantil Prof. Fernando Figueira