Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Mean daily ultrafiltration (UF)
研究概览
简要总结
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Informed consent signed and dated by study patient and investigator/authorised physician
- •CKD patients being treated with APD for at least 3 months
- •Minimum age of 18 years
- •Body weight ≥ 40 kg
- •Fluid status regularly monitored with Body Composition Monitor (BCM)
- •Patients planned to change to the Silencia PD cycler
- •Proper functioning catheter
- •Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter "permitted patient volume"
- •Ability to understand the nature and requirements of the study
排除标准
- •Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- •Patients receiving polyglucose containing PD solution
- •Any conditions which could interfere with the patient's ability to comply with the study
- •Patients who suffer from peritonitis/exit site infection during the last 4 weeks
- •Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
- •Life expectancy < 3 months
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
研究组 & 干预措施
Peritoneal dialysis PD
Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler depending on the previous treatment (clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).
干预措施: PD cycler Silencia (Device)
结局指标
主要结局
Mean daily ultrafiltration (UF)
时间窗: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Daily ultrafiltration reached by the Patient with APD
Total Kt/V urea
时间窗: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Measurement of solute removal during peritoneal dialysis focuses on urea
Achieving Kt/Vurea ≥ 1.7
时间窗: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Measurement of solute removal during peritoneal dialysis focuses on urea
次要结局
未报告次要终点