Evaluation of a Blood Potassium Measurement Device From Capillary Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioRenal
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device
研究概览
简要总结
This is an open, prospective, and interventional study investigating the potassium measurement with the CardioRenal device in capillary blood. It will be conducted at one investigational site.
Each subject will have capillary blood collections. Additionally as a reference a venous blood collection will be conducted
详细描述
Cardiorenal is a company aiming to develop in-vitro diagnostic medical devices to measure the potassium from a single drop of capillary blood to allow an everyday home monitoring of the potassium value like with the diabetes patients who supervise their blood sugar level by measurements with glucose-test stripe from a drop of capillary blood.
A major problem for the blood potassium monitoring at clinical levels is caused by hemolysis leading to the overestimation of potassium level. Hemolysis is the lysis of red blood cells (RBC, erythrocytes) and the release of their contents into plasma. The hemolysis may occur from in vivo or in vitro causes (milking, pressure...). It has also been reported that capillary puncture may induce increased level of hemolysis compared to venous sampling.
CardioRenal aims to limit those factors to guarantee an accurate measurement of potassium concentration in a capillary sample by using a standardized method of capillary pricking.
After clarification the approval the Informed Consent is signed and the inclusion as well as exclusion criteria (incl. demography, concomitant medication and medical history) or vital parameters (weight), are raised.
With 40 healthy subjects capillary and venous blood is taken. Blood is taken from the subject by trained specialist staff. The capillary blood sampling occurs in 400 µl Lithium-Heparin BD vacutainer Microtainers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Adults (Age Over 18 yo)
- •Healthy volunteers
- •Chronic Hemodialysed patients
- •Pre-dialysis patient, taken off after the long interdialytic interval (> 2 days)
- •AND with a K+ > 5.0 mmol/L just before starting the dialysis session (screening checked on venous or arterio-venous blood sample)
- •Post-dialysis, in patients treated with a 2 mmol/l dialysis bath
- •AND with a K+ < 3.5 mmol/L at the end of the dialysis session (screening checked on venous or arterio-venous blood sample)
排除标准
- •No consent
- •Age <18 yo
- •Medical history of crisis (epilepsy)
- •Known inherited hemolytic anemia
- •Autoimmune hemolytic anemia
- •Infectious Hemolytic anemia
- •Prosthetic Cardiac valves
- •Hemolytic uremic syndrome
- •Peripheral edema
- •Dehydration
- •Peripheral Arterial Obstructive Disease (PAOD)
- •Raynaud syndrome
- •Known evolutive cancers
- •Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken
结局指标
主要结局
Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device
时间窗: through study completion, an average of 1 month
次要结局
- Correlation between capillary potassium with available point of care device and capillary potassium with Cardiorenal device(through study completion, an average of 1 month)
- Correlation between plasma potassium from venous puncture with lab test and plasma potassium from venous puncture with Cardiorenal device(through study completion, an average of 1 month)
- Correlation between plasma potassium from venous puncture with lab test and capillary potassium with Cardiorenal device(through study completion, an average of 1 month)
- Correlation between venous whole blood potassium and capillary potassium measurement with available point of care device(through study completion, an average of 1 month)