GAMMA Study: Patient Self-testing of Capillary Blood Potassium: A Validation Study and Measurement Performance in Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2024-03-31

Brief Summary

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Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.

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Detailed Description

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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.

Conditions

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Potassium Measurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Potassium measurement

Calibration Phase : 1 visit (duration 1 day) for subjects not on dialysis and hemodialysis patients Comparaison Phase : 1 visit (diration 1 day) for hemodialysis patients Comparaison Phase : 2 visits (diration 1 day) for subjects not on dialysis

Group Type EXPERIMENTAL

Device: Self testing Potassium device

Intervention Type 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

Interventions

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Device: 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

* 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)

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes