Detecting Local and Systemic Fluid Accumulation With a Wearable Bioimpedance Sensor in Patients With Fluid Management Problems (DELOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
研究概览
简要总结
The investigation is a prospective cohort study, where two patient groups will be monitored by a wearable bioimpedance sensor during their scheduled treatment. The overall objective is to assess the bioimpedance sensor's ability to detect local and systemic fluid accumulation.
Sub-investigation A will investigate the ability of the device to detect fluid accumulation in patients with stable chronic kidney disease undergoing regular and planned hemodialysis.
Sub-investigation B will investigate the ability of the device to track hydration status in patients scheduled for an "intensive" dialysis treatment regime, due to severe overhydration.
详细描述
In Sub-investigation A, patients will be monitored for at least 10 consecutive dialysis sessions, and for a minimum of 3 weeks. Patients will wear two sensors (upper back and lower anterior leg).
In Sub-investigation B, patients will use the device throughout their whole treatment period, and for most patients, this will correspond to 2-6 dialysis treatments over 3 to 10 days. Patients will wear four patches (upper back, lateral thorax, anterior thigh, and lower anterior leg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age ≥ 18 years
- •Regular hemodialysis (≥ 2 times weekly) with ultrafiltration volume ≥ 1 liter (Sub-investigation A)
- •Scheduled for intensive dialysis treatment due to severe overhydration (Sub-investigation B)
排除标准
- •Known allergies or skin sensitivities to electrode hydrogel and/or acrylic adhesives
- •Implantable pulse generators such as pacemakers and defibrillators, and/or use of other electrical medical equipment for which an interaction effect with the investigational device cannot be ruled out.
- •Patients undergoing MRI
- •Breached skin at patch mounting area
- •Pregnancy
- •Any medical or psychiatric condition, which in the opinion of the investigator precludes participation
研究组 & 干预措施
Patients with chronic kidney failure
Patients with chronic kidney failure will wear bioimpedance sensors at the upper back and lower anterior leg for three weeks.
干预措施: Wearable bioimpedance sensor (Device)
Patients with severe overhydration
Patients with severe overhydration will wear bioimpedance sensors at the upper back, lateral thorax, anterior thigh, and lower anterior leg throughout an intensive dialysis treatment regime (~2-10 days).
干预措施: Wearable bioimpedance sensor (Device)
结局指标
主要结局
The effect of interdialytic fluid accumulation on the extracellular resistance of the upper back in stable chronic dialysis patients
时间窗: 1-4 days
Relative change in extracellular resistance of the upper back, measured by the bioimpedance device in the interdialytic period in Sub-investigation A
次要结局
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the lower anterior leg in patients with severe overhydration(2-10 days)
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the lateral thorax in patients with severe overhydration(2-10 days)
- Safety of the investigational device(Up to 4 weeks)
- The effect of interdialytic fluid accumulation on the extracellular resistance of the lower anterior leg in stable chronic dialysis patients(1-4 days)
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the upper back in patients with severe overhydration(2-10 days)
- The effect of an intensive dialysis treatment regime on the extracellular resistance of the anterior thigh(2-10 days)