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

January 22, 2024 updated by: CardioRenal
Multicentre, open, prospective and interventional study investigating the CardioRenal device in capillary blood of patients.It will be conducted at multiple investigational sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Grenoble, France
        • Recruiting
        • CHU Grenoble-Alpes
        • Contact:
      • Grenoble, France
        • Recruiting
        • Centre d'investigation Clinique
      • La Tronche, France
        • Recruiting
        • Agduc La Tronche
        • Contact:
          • Philippe Zaoui
      • Marseille, France
      • Marseille, France
      • Meylan, France
        • Recruiting
        • Biogroup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calibrations factors and correlations R²
Time Frame: through study completion, an average of 3 months
potassium values
through study completion, an average of 3 months
Accuracy of measurement of the capillary whole blood potassium with TENOR compared to the reference method (indirect potentiometry)
Time Frame: through study completion, an average of 3 months
potassium values
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of mean, standard deviation (SD) and coefficient of variation (CV)
Time Frame: through study completion, an average of 3 months
repeatability
through study completion, an average of 3 months
Usability Evaluation questionnaire
Time Frame: through study completion, an average of 3 months
through study completion, an average of 3 months

Other Outcome Measures

Outcome Measure
Time Frame
Record and evaluate adverse events
Time Frame: through study completion, an average of 3 months
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioRenal

Investigators

  • Principal Investigator: Pierre-Louis Carron, MD, CHU Grenoble-Alpes Service de Nephrologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR-2023-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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