Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,092
- 试验地点
- 134
- 主要终点
- Hydration status
研究概览
简要总结
The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.
详细描述
Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.
It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.
The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.
The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.
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
- •Incident patients directly before start of peritoneal dialysis
- •Patients in whom routine measurement of body composition monitoring is performed
排除标准
- •Patients treated with HD before start of PD
- •Patients in whom body composition monitoring cannot be performed
结局指标
主要结局
Hydration status
时间窗: Every three months over a period of four years
Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))
次要结局
- Changes in PD prescription(Four years)
- Residual renal function(Every three months over a period of four years)
- Peritoneal transport status(Every three months over a period of four years)
- Time to change to haemodialysis(Four years)