Observational Study of Bioimpedance Spectroscopy (BIS) for Use in a Renal Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- BIS correlation with amount of fluid dialyzed
研究概览
简要总结
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
详细描述
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.
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
- •Age >=18 years of age;
- •End-stage renal disease with a GFR <15 mL/min/1.73m^2 and dialysis dependent requiring 3-times weekly dialysis;
- •Able and willing to remove shoes and stand on SOZO for BIS measurements;
- •Able to provide written informed consent and authorization to use and disclose health information.
排除标准
- •Is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion;
- •Has a clinical condition that would not allow them to complete the study;
- •Is pregnant or planning to become pregnant; women of childbearing potential (or premenopausal) must be on 2 forms of contraception;
- •Is lactating;
- •Has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator);
- •Has an amputation of a limb/s resulting in them being unable to make contact with the SOZO electrodes (amputations of fingers and toes are not an exclusion);
- •Patient determined by the attending physician unlikely to be compliant with study procedures.
结局指标
主要结局
BIS correlation with amount of fluid dialyzed
时间窗: 12 hemodialysis sessions (over 4 to 6 weeks)
BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.
次要结局
未报告次要终点