Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side
研究概览
简要总结
The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. Abnormal high water distribution is defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will cover 50 adults. Men and women in an age range of 18 to 65 years and a Body Mass Index (BMI) range of 18.5 to 35 kg/m2 should be equally distributed. Subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. Patients that are taken before dialysis treatment should have been dialysed two and not three days before.
排除标准
- •amputation of limbs
- •gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis
- •bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia
- •electrical implant as cardiac pacemaker
- •insulin pumps
- •pregnancy or breastfeeding period
- •subjects who cannot provide an Informed Consent Form (ICF) by themselves
- •subjects who might be dependent from the sponsor or the investigation site
结局指标
主要结局
Bioelectrical impedance (Resistance and Reactance) of 5 and 50 kHz for the right body side
时间窗: about 2 minutes
The measurements are utilized as input for prediction equations to calculate TBW and ECW.
次要结局
- Bioelectrical impedance (Resistance and Reactance) of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz(about 2 minutes)
- TBW(within 4 hours)
- ECW(within 4 hours)