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临床试验/NCT01229592
NCT01229592终止不适用

Clinical Study of Ethanol Lock-therapy in the Prevention of Non-tunnelled, Short Term Central Venous Catheter Associated Infections

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Every three day lock using Ethanol in all the lumen of the Catheter

干预措施: Ethanol (Drug)

Heparine

Active Comparator

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)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Sponsor

研究点 (1)

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