Potassium MeasurementALPHANCT04907773
Evaluation of a Blood Potassium Measurement Device From Capillary Samples (ALPHA)
A study testing Capillary blood sampling, Venous blood sampling and Arterio-venous blood sampling in people with Potassium Measurement, run by CardioRenal at 1 site in Belgium.
Trial 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 subject will have capillary blood collections. Additionally as a reference a venous blood collection will be conducted Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potassium Measurement
- What is being tested?
- Capillary blood sampling, Venous blood sampling and Arterio-venous blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- No consent
- Age <18 yo
- Medical history of crisis (epilepsy)
- Known inherited hemolytic anemia
- Autoimmune hemolytic anemia
- Infectious Hemolytic anemia
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Blood Potassium Measurement Device From Capillary Samples
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
Read the 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 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.
- A total of <1mL volume of capillary blood is taken.
- In addition 10 ml blood from the vein of a forearm is taken.
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.
- A screening based on potassium measurement just before the capillary puncture is performed to test the eligibility of the subject : a 2.5mL blood is taken from the fistula or the central venous catheter.
- A total of <1mL volume of capillary blood is taken.
- In addition 10 ml blood from the fistula or the central venous catheter.
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.
- Conditions
- Potassium Measurement
- Being tested
- Capillary blood sampling, Venous blood sampling, Arterio-venous blood sampling
- Keywords
- hemolysis, capillary collection
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary blood samplingOther
Each subject will have one to two capillary blood collections.
Venous blood samplingOther
Each healthy subject will also have a reference venous blood collection.
Arterio-venous blood samplingOther
Each hemodialysed subject will also have a reference arterio-venous blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Potassium measurement | Other | Not described Receives: Other: Capillary blood sampling; Other: Venous blood sampling; Other: Arterio-venous blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device
Measured: through study completion, an average of 1 month
Secondary outcomes (4)
Correlation between capillary potassium with available point of care device and capillary potassium with Cardiorenal device
Measured: through study completion, an average of 1 month
Correlation between plasma potassium from venous puncture with lab test and capillary potassium with Cardiorenal device
Measured: through study completion, an average of 1 month
Correlation between venous whole blood potassium and capillary potassium measurement with available point of care device
Measured: 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
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jul 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potassium MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Potassium measurement
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioRenal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damien Gruson, Prof, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907773
- Sponsor's protocol ID
- CR-2021-001
- Acronym
- ALPHA
- Status last verified
- Sep 2021
- First submitted
- 21 May 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Blood Potassium Measurement Device From Capillary Samples
- ClinicalTrials.gov ID
- NCT04907773
- Acronym / sponsor ID
- ALPHA / CR-2021-001
- Conditions
- Potassium Measurement
- Keywords
- hemolysis, capillary collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CardioRenalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
- A total of <1mL volume of capillary blood is taken.
- In addition 10 ml blood from the vein of a forearm is taken.
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.
- A screening based on potassium measurement just before the capillary puncture is performed to test the eligibility of the subject : a 2.5mL blood is taken from the fistula or the central venous catheter.
- A total of <1mL volume of capillary blood is taken.
- In addition 10 ml blood from the fistula or the central venous catheter.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Potassium measurement
| Arm | Type | Receives |
|---|---|---|
| Potassium measurement | Other | Other: Capillary blood sampling, Other: Venous blood sampling, Other: Arterio-venous blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- No consent
- Age <18 yo
- Medical history of crisis (epilepsy)
- Known inherited hemolytic anemia
- Autoimmune hemolytic anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary blood samplingEach subject will have one to two capillary blood collections. | Other | Potassium measurement |
| Venous blood samplingEach healthy subject will also have a reference venous blood collection. | Other | Potassium measurement |
| Arterio-venous blood samplingEach hemodialysed subject will also have a reference arterio-venous blood collection. | Other | Potassium measurement |
Primary outcome
Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device
Time frame: through study completion, an average of 1 month
4 secondary outcomes
Correlation between capillary potassium with available point of care device and capillary potassium with Cardiorenal device
Time frame: through study completion, an average of 1 month
Correlation between plasma potassium from venous puncture with lab test and capillary potassium with Cardiorenal device
Time frame: through study completion, an average of 1 month
Correlation between venous whole blood potassium and capillary potassium measurement with available point of care device
Time frame: 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
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien Gruson, Prof principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capillary blood sampling, Venous blood sampling and Arterio-venous blood sampling in people with Potassium Measurement, run by CardioRenal at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between venous whole blood potassium with available point of care device and capillary potassium with CardioRenal device (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.