Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 821
- 试验地点
- 1
- 主要终点
- SIRS
研究概览
简要总结
The purpose of this study is to determine whether the use of in-line filtration shows any effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis, or organ failure in critically ill children admitted to the pediatric intensive care unit (PICU).
详细描述
Scientific background:
Particulate contamination of infusion solutions and their systemic administration during infusion therapy has been linked to various clinical problems.
Organ failure and Multi-Organ Failure (MOV):
It is well established that the pathophysiology of MOV involves deteriorations of the microcirculation and integrity of endothelial cells. As a consequence of this an imbalance between pro- and anticoagulatory factors may develop and microthrombi may form. Mediators like tissue factor (TF) and platelet activating factor (PAF) have been linked to the formation of microthrombi.
Particles have been discussed as a causative agent for this syndrome by various authors. Their effect on morbidity and mortality of patients has however not yet been established.
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
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
- •Children admitted to pediatric intensive care unit (PICU)
排除标准
- •Suspected death within 48 hours
- •Duration of PICU stay less than 6 hours
- •Patients recruited for Simulect or Sintra Study
结局指标
主要结局
SIRS
Sepsis
Thrombosis
Organ failure
Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
次要结局
- Duration of overall hospital stay
- Duration of Pediatric Intensive Care Unit stay