Haemodialysis Outcomes & Patient Empowerment Study 02
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accuracy of Sixty device versus bioimpedance
研究概览
简要总结
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
详细描述
Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.
The Sixty device uses diffuse reflectance spectroscopy to measure fluid status.
20 patients will be assessed during the study observation period.
10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period.
Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •On haemodialysis in an ambulatory care setting.
- •Demonstrates understanding of correct use of the Sixty device.
- •Capable and willing to measure blood pressure at home on a daily basis.
- •Willing to give written informed consent.
排除标准
- •Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
- •Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
结局指标
主要结局
Accuracy of Sixty device versus bioimpedance
时间窗: 3 weeks
The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM)
次要结局
- Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis(3 weeks)
- Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring(3 weeks)
- Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session(3 weeks)
- Comparison of changes in volume status as determined by Sixty device versus blood pressure(3 weeks)
- Acceptability of Sixty device(3 weeks)