NCT01544686已完成不适用
Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 10
- 主要终点
- Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
研究概览
简要总结
In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.
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
- •Patients receiving a central venous catheter for chemotherapy of AML or ALL
- •Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
- •Age >= 18 years
排除标准
- •Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
- •Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
- •Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
- •Patients previously enrolled in the study
- •Tunneled central venous catheters
- •Shaldon catheters
- •CVC insertion via the V. femoralis
- •Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
- •Known allergic/hypersensitivity reaction to any compounds of the treatment
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
结局指标
主要结局
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
时间窗: 14 days
Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter
次要结局
- Incidence of definite catheter related bloodstream infection-related severe sepsis during the first 14 days after placement of the central venous catheter(14 days)
- Definite catheter-related bloodstream infection-related mortality during the first 14 days after placement of the central venous catheter(14 days)
- Overall incidence of catheter-related bloodstream infection(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Overall catheter-related bloodstream infection-related severe sepsis(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Overall mortality(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Time to first neutropenic fever(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Tolerability/safety(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Rate of unplanned changes(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Overall catheter-related bloodstream infection-related mortality(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Time to removal of central venous catheter(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
- Time to central venous catheter-related blood stream infections(From placement of the central venous catheter until the follow-up at a maximum of 56 days)
研究者
Maria J.G.T. Vehreschild
Principal Investigator
University of Cologne
研究点 (10)
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