Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Rate of Device-related Bacteremia
研究概览
简要总结
This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.
详细描述
The study is a randomized, double blinded, prospective, multicenter, clinical trial. All patients requiring vascular access with a tunneled central venous catheter for hemodialysis are eligible for enrollment. Patients will be randomized to receive either Heparin 1,000 U/ml in a volume sufficient to fill the catheter length in both ports or to receive 4% Sodium Citrate with Gentamicin 320 mcg/mL in a volume sufficient to fill the catheter length in both ports.We hypothesize that the device related infection rate in the Citrate/Gentamicin group will be less than the heparin arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
- •Must be at least 18 years old
- •Compliant with a dialysis treatment schedule
- •Plans to continue hemodialysis treatment and follow-up at the investigational site
- •Must be able to care for the exit site independently or have someone who is able to care for the site for them
- •Must be able to sign the informed consent document
排除标准
- •The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
- •Active exit site or tunnel infection
- •Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
- •Known to have antibodies to heparin
- •Allergy to pork heparin
- •Allergy to gentamicin
- •Subject is pregnant
- •Known intravenous drug abuse
研究组 & 干预措施
1
Catheter lock with heparin 1,000 units/mL
干预措施: Heparin 1000U/mL (Drug)
2
Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%
干预措施: 4% Sodium Citrate with Gentamicin 320 mcg/mL (Drug)
结局指标
主要结局
Rate of Device-related Bacteremia
时间窗: 5 years
Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection
次要结局
- Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow(5 years)