PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 50
- 主要终点
- Hydration status
研究概览
简要总结
The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.
详细描述
In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.
The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •CKD patients with indication for renal replacement therapy
- •Patient treated or to be treated with aAPD
- •Fluid status regularly monitored with BCM
排除标准
- •Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
- •Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
结局指标
主要结局
Hydration status
时间窗: Every three months during one year
Assessed via body composition measurements
次要结局
- Residual renal function(Every three months during one year)
- Changes in prescription(Every three months during one year)
- Achievement of adequate solute removal(Every three months during one year)
- Therapy tolerability(Every three months during one year)