NCT07004907尚未招募不适用
Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 13
- 主要终点
- Total weekly Kt/V urea
研究概览
简要总结
The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated by legal representative and investigator/authorized physician
- •The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
- •The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
- •patients with renal failure treated or planned to be treated with APD
- •Body weight ≤ 20 kg
- •Ability to understand the nature and requirements of the study
排除标准
- •Any conditions which could interfere with the patient's ability to comply with the study
- •Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
- •Life expectancy < 3 months
- •Patients who suffer from peritonitis/exit site infection during the last 4 weeks
结局指标
主要结局
Total weekly Kt/V urea
时间窗: The primary endpoint is total Kt/Vurea at week 2 and 4
The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.
次要结局
- Residual renal function (RRF)(RRF will be measured at weeks 2 and 4)
- Mean daily ultrafiltration (UF)(Mean UF will be measured at weeks 2 and 4)
研究者
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