A Randomised Controlled Trial Comparing the Effectiveness of Heparin Bonded or Antibiotic Impregnated Central Venous Catheters (CVCs) With Standard CVCs for the Prevention of Hospital Acquired Blood Stream Infection in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,859
- 试验地点
- 2
- 主要终点
- The primary outcome will be time to first blood stream infection defined by a positive blood culture from a sample that was clinically indicated and taken more than 48 hours after CVC insertion and up to 48 hours after CVC removal.
研究概览
简要总结
Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots.
Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance.
Each child in the trial will have the same chance of getting any of these three catheters:
- Standard central venous catheter (not coated).
- Heparin coated central venous catheter. Heparin is a medicine that can stop blood from clotting and might stop the tubes being blocked and infections in the blood.
- Antibiotic coated central venous catheter. Antibiotics can be used to kill bacteria which cause the infections.
The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weighing ≥3kg and less than 16 years of age;
- •Admitted to or being prepared for admission to an intensive care unit participating in the trial;
- •Require insertion of a polyurethane CVC as part of good clinical management;
- •Require one of the CVC sizes available to the trial (see Appendix A for the list of CVCs);
- •Expected to require a CVC for at least 3 days;
- •Appropriate consent obtained (prospective consent for elective surgical patients, deferred consent for emergency admission patients).
排除标准
- 未提供
结局指标
主要结局
The primary outcome will be time to first blood stream infection defined by a positive blood culture from a sample that was clinically indicated and taken more than 48 hours after CVC insertion and up to 48 hours after CVC removal.
时间窗: 48 HOURS
次要结局
未报告次要终点