GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CardioRenal
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Calibrations factors and correlations R²
研究概览
简要总结
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
详细描述
Objectives are to assess the quantitative accuracy in freshly collected whole capillary blood from patients and healthy volunteers and to evaluate user proficiency. In order to gather a wide range of K+ concentrations, the study will be conducted both on patients or healthy volunteers and on dialysis patients.
The study includes 2 phases (calibration phase and comparison phase) where blood samples (capillary and venous) will be collected.Blood is taken from the subject by trained specialist staff. During the comparison phase, the subjects will be equipped with CardioRenal device and trained to do the self-test.
A subject's participation in this study (both calibration and validation phase) will consist of two interventional visits for hemodialysis patients and three interventional visits for other subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Calibrations factors and correlations R²
时间窗: through study completion, an average of 3 months
potassium values
Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry)
时间窗: through study completion, an average of 3 months
potassium values
次要结局
- Determination of mean, standard deviation (SD) and coefficient of variation (CV)(through study completion, an average of 3 months)
- Usability Evaluation questionnaire(through study completion, an average of 3 months)