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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
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.
With 30 hemodialysed subjects capillary and venous blood is taken before and/or after dialysis session to extend the potassium concentration range. Blood is taken from the subject by trained specialist staff. The capillary blood sampling occurs in 400 µl Lithium-Heparin BD vacutainer Microtainers.
To guarantee a light blood decrease without strong mechanical pressure, the site for capillary puncture are warmed up before the capillary sampling during 2 minutes before puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium measurement | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capillary blood sampling | Other | Each subject will have one to two capillary blood collections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device | through study completion, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 capillary potassium with Cardiorenal device |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation from capillary freeHb and capillary potassium | through study completion, an average of 1 month | |
| Degree of haemolysis in capillary blood tests compared to venous blood test | through study completion, an average of 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien Gruson, Prof | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | Belgium |
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| ID | Term |
|---|---|
| D006461 | Hemolysis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Potassium measurement
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| Venous blood sampling | Other | Each healthy subject will also have a reference venous blood collection. |
|
| Arterio-venous blood sampling | Other | Each hemodialysed subject will also have a reference arterio-venous blood collection. |
|
| 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 |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |