Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Sensitivity Analysis
研究概览
简要总结
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
详细描述
The objective of this study is to explore the utility of hemodynamic biomarkers measured by the Bodyport Cardiac Scale in predicting worsening events attributable to fluid overload among those with kidney disease on peritoneal dialysis. The study will explore individual biomarkers, as well as composite biomarker indices, such as the Congestion Index and a novel PD Index.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older
- •Able to speak and read English, or able to speak and read Spanish and has a caregiver or family member who speaks English and can provide assistance
- •Able to stand on two bare feet unassisted
- •Receiving automated peritoneal dialysis for the treatment of ESKD
- •Followed on the Vantive Sharesource Remote Patient Management Platform
排除标准
- •Undergoing or plan to undergo hemodialysis in the next 12 months
- •Have a life expectancy of less than 12 months
- •Are pregnant or plan to become pregnant during the next 12 months
- •Weigh greater than 375 lbs
- •Planned kidney transplant within the next 12 months
- •Have an implanted neurostimulator system
研究组 & 干预措施
PD Patients
Patients with kidney disease on peritoneal dialysis.
干预措施: Bodyport Cardiac Scale (Device)
结局指标
主要结局
Sensitivity Analysis
时间窗: 1 year
Sensitivity for predicting usable PDE \> 0.40 and an alert rate of \< 4.3 alerts per patient-year.
次要结局
- Peritoneal Dialysis (PD) Events(1 year)