Potassium Measurement
Conditions
Keywords
self-test, capillary collection, in-vitro diagnostic medical device
Brief summary
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.
Detailed description
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.
Interventions
DEVICEDevice: Self testing Potassium device
Calibration Phase (1 visit) (Hemodialysis patients and subjects not on dialysis) Each patient will have one venous blood collection. Among them, one 30 patients one capillary sample is collected. In this phase, the HCP is the user of the device. Comparison Phase For subject not on dialysis (total 2 visits): Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test For Hemodialysis patients (total 1 visit) : Each patient will have one venous blood collection per visit Each patient will be equipped with CardioRenal device and trained to do the self-test
Sponsors
CardioRenal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for subjects not on dialysis: * Male/female subject, aged 18+ years ; * Signing a written informed consent ; * Willing to perform the self-test after viewing the instruction for use; * Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Inclusion Criteria for hemodialysis patients: * Male/female subject, aged 18+ years ; * Medical history of dyskalemia ; * Signing a written informed consent ; * Willing to perform the self-test after viewing the instruction for use; * Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Non-inclusion Criteria for subjects not on dialysis: * Medical history of seizure (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) stage 4 * Raynaud syndrome * Known evolutive cancers * Subjects who are pregnant or breast-feeding * 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 * Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development * Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities \> 6000 euros for a 12-months period) Non-inclusion Criteria for hemodialysis patients: * Medical history of seizure (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) stage 4 * Raynaud syndrome * Known evolutive cancers * Subjects who are pregnant or breast-feeding * 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 * Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development * Subject who is prohibited from participation in the study after consulting the Ministry of Health National File (e.g. indemnities \> 6000 euros for a 12-months period)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calibrations factors and correlations R² | 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) | through study completion, an average of 3 months | potassium values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of mean, standard deviation (SD) and coefficient of variation (CV) | through study completion, an average of 3 months | repeatability |
| Usability Evaluation questionnaire | through study completion, an average of 3 months | — |
Other
| Measure | Time frame |
|---|---|
| Record and evaluate adverse events | through study completion, an average of 3 months |
Countries
France
Contacts
Primary ContactMaurice BERENGER, PhD
Outcome results
None listed