Prevention of Tunneled Cuffed Hemodialysis Catheter-Related Dysfunction and Bacteremia by the TEGO® Connector: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
研究概览
简要总结
The aim of the trial was to assess whether use of the TEGO connector was able to reduce the incidence of a composite endpoint of TCC-related dysfunction (TCC-D)or TCC-related bacteremia (TCC-B) in chronic hemodialysis (HD) patients carrying the TEGO® connector vs controls receiving trisodium citrate 46.7%.
详细描述
The TEGO® connector (ICU Medical, www.icumed.com) is a closed positive pressure system, flushed with 0.9% sodium chloride and attached on the hubs of the TCC. As recommended by the producer, the TEGO® remains during 3 consecutive HD sessions and is changed every week. By constituting a mechanical barrier, it could be an interesting alternative to reduce the intraluminal contamination and the risk of TCC-B.
The TEGO® connector is supposed to provide an automatic positive displacement of fluid at the end of each TCC flush. This positive pressure could prevent the reflux of blood into the TCC lumen, possibly resulting in TCC-D.
As the impact of the TEGO® connector on TCC-D and TCC-B has never been studied, we conducted a randomized controlled study in our center by comparing the anti-thrombotic and anti-infectious efficacy of the TEGO® connector to trisodium citrate 46.7% (Citralock®, Dirinco, www.citra-lock.com) . The global cost of both procedures was also evaluated.
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
- •Adult HD patients, prevalent or incident,carrying a tunneled cuffed catheter
- •Tunneled cuffed catheter providing a mean blood flow superior to 250 ml/min
- •Patients having signed an informed consent
排除标准
- •Mature arterio-venous fistula
- •Episode of TCC-related bacteremia 1 week before randomization
研究组 & 干预措施
TEGO® connector
The TEGO® connector is used during 3 consecutive hemodialyse. After each dialysis session, the dead space of the catheter is flushed with NaCl 0.9%.
干预措施: TEGO connector® (Device)
Trisodium citrate
After each dialysis, the dead space of the catheter is filled with trisodium citrate 46.7% (Citralock®).
干预措施: Trisodium citrate (Drug)
结局指标
主要结局
Incidence rate of tunneled cuffed catheter-related dysfunction or bacteremia (composite endpoint)
时间窗: 16 months
Tunneled cuffed catheter dysfunction was defined by the requirement of urokinase and/or a mean blood flow \< 250 ml/min during two consecutive hemodialysis sessions. Tunneled cuffed catheter bacteremia was defined by ≥ 2 positive qualitative and/or quantitative positive blood cultures.
次要结局
未报告次要终点
研究者
Joëlle Nortier, MD, PhD
MD, PhD
Erasme University Hospital