Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 630
- 试验地点
- 5
- 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
研究组 & 干预措施
3M™ Tegaderm CHG IV
Patients receive the 3M Tegaderm CHG IV securement dressing after placement of a central venous catheter.
干预措施: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV (Device)
3M™ Tegaderm™ Advanced IV'
Patients receive the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
干预措施: 3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV (Device)
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