Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 192
- 主要终点
- Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
研究概览
简要总结
Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.
Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.
This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •New hemodialysis catheter
- •Subject who will need chronic hemodialysis at least twice/week
- •Subject likely to require for at least 120 days
- •Subject or relative is likely to understand the nature of the study and sign the consent
- •Age 18 years and older
排除标准
- •Subject with unstable malignancy
- •Subject with liver cirrhosis with encephalopathy
- •Subject know to have allergy to heparin, citrate or traoulidine
- •Documented history of arterial thrombosis or known to have hypercoagulable state
- •Subjects with active skin infections and ulcers
研究组 & 干预措施
Heparin group
干预措施: Heparin (Drug)
Neotrolin Group
干预措施: Neutrolin (Device)
结局指标
主要结局
Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
时间窗: 18 month
Rate of hemodialysis catheter in each study arm
次要结局
- Proportion of hemodialysis catheters with poor flow due to thrombosis(18 month)
研究者
Dr. Mubarak Al Abdalla
Consultant Nephrologist and Assistant Professor
King Abdullah International Medical Research Center