Status:
COMPLETED
Evaluation of a Blood Potassium Measurement Device From Capillary Samples (ALPHA)
Lead Sponsor:
CardioRenal
Conditions:
Potassium Measurement
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 s...
Detailed Description
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 valu...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04907773
Start Date
July 1 2021
End Date
October 15 2021
Last Update
November 1 2021
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium