Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- the differential time to positivity
研究概览
简要总结
Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic methods have been recently developed. The aim of the study is to evaluate three catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of the area around the insertion site of the CVC.
详细描述
Samples for the three techniques described above will be collected from the children admitted in Pediatric Intensive Care Unit with a CVC for more than 48 hours and with clinical or biological signs of systemic infection. Any investigation required to determine the origin of the infection will be performed, according to physician's judgement. If the CVC is removed or changed on a guide wire, a quantitative culture of the distal segment will be performed.
All the patients with a bloodstream infection and sampled according to the protocol will be included for statistical analysis. The physician and an independent medical expert will analyse if the bloodstream infection is CVC-related or not, according to the reference standard, by analysis of the clinical and bacteriological data, blinded towards the three studied techniques. The most optimal threshold will be determined and the sensibility, the specificity, the positive and negative predictable value of the three techniques will be calculated. Then sensibility of these three techniques will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 0 and 18 years.
- •Presence of a Central Venous Catheter for more than 48h (excepted umbilical catheter or peripherally inserted central catheters)
- •Presence of at least one clinical or biological sign of systemic infection
- •Parents are informed of the protocol and don't refuse the inclusion
- •Prior inclusion in this study for the same bloodstream infection
排除标准
- 未提供
结局指标
主要结局
the differential time to positivity
时间窗: maximum 24 hours
To determine the sensibility, the specificity, the positive and negative predictible value of the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC, compared to the reference standard
次要结局
- acridine orange leucocyte cytospin test.(maximun 24 hours)
- semi-quantitative skin culture(maximum 24 hours)
- acridine orange leucocyte cytospin test.(maximun 24 hours)
- semi-quantitative skin culture(maximum 24 hours)