Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- catheter infectionrelated incidence rates
研究概览
简要总结
In recent years, several new methods for treatment of catheter-related bloodstream infections (CRBSI) such as antibiotic or antiseptic lock-therapy have been developed with variable success [1-10].
Long-term tunnelled central venous catheters provide a reliable access for administration of chemotherapy, parenteral nutrition or haemodialysis. However, they are not free of complications such as bacteremia. The need to preserve these intra-vascular devices as long as is possible in patients in whom conventional treatment was failed makes emerge antibiotic lock-technique.
Ethanol lock-therapy was demonstrate her utility in this cases. But no study has yet been published using the ethanol lock-therapy as a prophylactic therapy in catheter related infections, neither her application in short-term CVCs.
Objectives: To investigate the value of a ethanol-lock solution in the prophylaxis of non-tunnelled short-term CVC related infections in a heart post-surgical intensive care unit (HPSICU).
Methods: An academic, prospective, randomized and controlled clinical trial is proposed. Patients at HPSICU who have a CVC more than 48 h will be randomized in two arms (ethanol-lock or control group with conventional measurements such as anticoagulants). In the follow-up period, we will register all necessary data to evaluate the end-points of study (CBRSI rate, catheter colonization rate, hospital stay, antimicrobial consume and adverse events due to ethanol).
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old
- •Signed informed consent
- •central Venous catheter more than 48 hours placed
排除标准
- •pregnancy
- •denial Informed consent Form
- •ethanol intolerance
- •Liver cirrhosis
研究组 & 干预措施
Ethanol
Every three day lock using Ethanol in all the lumen of the Catheter
干预措施: Ethanol (Drug)
Heparine
Every three day lock using Heparine in all the lumen of the Catheter
干预措施: Heparine (Drug)
结局指标
主要结局
catheter infectionrelated incidence rates
时间窗: 2 years
decrease on catheter infection related incidence rates in comparison to the institution incidence figures
次要结局
- cathether bacteriaemia related rate(2 years)
- antimicrobial consume(2 years)
