Potassium (K) & Ionized Calcium (iCa) in Capillary Whole BloodNCT06295835
Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood
A study testing Fingerstick blood draw in people with Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood, run by Abbott Point of Care at 4 sites in 2 countries.
Trial summary
Method comparison study for Potassium (K) and ionized calcium (iCa). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood
- What is being tested?
- Fingerstick blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 May 2024to 29 Jan 2025
- 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
- Signed and dated consent form (if required by the IRB)
- ≥ 18 years of age
Who cannot join
- Prior enrollment in the study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Maryland (UMD)
Baltimore, Maryland, 17033
Penn State University Hershey Medical Center (Hershey)
Hershey, Pennsylvania, 17033
Eastside Research Associates (ERA)
Redmond, Washington, 98052
About this study
Official title: Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
Method comparison study for Potassium (K) and ionized calcium (iCa).
Read the detailed description
The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.
- Being tested
- Fingerstick blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick blood drawDiagnostic test
Capillary blood specimen collected from two separate fingersticks.
| Study group | Role | What they receive |
|---|---|---|
| Method comparison for K and iCa Tests using capillary whole blood specimens. | Other | Compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens collected from two separate fingersticks. Receives: Diagnostic Test: Fingerstick blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance comparison
Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device.
Measured: Up to 5 minutes
Performance comparison
Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device.
Measured: Up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start31 May 2024
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potassium (K) & Ionized Calcium (iCa) in Capillary Whole BloodStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, BS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295835
- Sponsor's protocol ID
- CS-2024-0001
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
- ClinicalTrials.gov ID
- NCT06295835
- Acronym / sponsor ID
- CS-2024-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 6 Mar 2024 (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.
Method comparison study for Potassium (K) and ionized calcium (iCa).
Detailed description
The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
| Arm | Type | Receives |
|---|---|---|
| Method comparison for K and iCa Tests using capillary whole blood specimens. | Other | Diagnostic Test: Fingerstick blood drawCompare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens collected from two separate fingersticks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated consent form (if required by the IRB)
- ≥ 18 years of age
Key exclusion criteria (1 listed)
- Prior enrollment in the study
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 |
|---|---|---|
| Fingerstick blood drawCapillary blood specimen collected from two separate fingersticks. | Diagnostic test | Method comparison for K and iCa Tests using capillary whole blood specimens. |
Primary outcome
Performance comparison
Time frame: Up to 5 minutes
Compare the performance of the Potassium (K) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K test on a comparator device.
Performance comparison
Time frame: Up to 5 minutes
Compare the performance of the ionized calcium (iCa) test using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the iCa test on a comparator device.
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 19 Mar 2025.
- 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.
Manish Gupta, BS, MBA study director
Abbott Point of Care
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fingerstick blood draw in people with Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood, run by Abbott Point of Care at 4 sites in 2 countries.
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 2 inclusion and 1 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Performance comparison (time frame: Up to 5 minutes). The study lists 2 primary outcomes in all. 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 19 Mar 2025.