Blood Tests for Potassium and Ionized Calcium Evaluation

Recruiting at 2 trial locations

Overseen By Miranda Gonzalez Aguirre, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Point of Care

Disqualifiers: Previous enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well two different blood test systems measure potassium and ionized calcium levels. Participants will have blood drawn from a fingerstick to compare results between the i-STAT 1 System and another blood analysis system. This trial suits adults who have not participated in this study before and can provide consent. As an unphased trial, it offers participants the chance to contribute to important research that could enhance blood testing methods.

What prior data suggests that this method is safe for blood testing?

Research has shown that the i-STAT CG8+ cartridge, used in the i-STAT 1 System, provides quick and accurate blood tests. It measures key blood components, such as potassium and ionized calcium, using a small sample often taken from a fingerstick.

Some safety information is important to note. A recall notice indicated that ionized calcium test results might be higher if the cartridge is stored at room temperature. While this does not directly impact safety, it underscores the importance of proper storage for accurate results.

Overall, blood draws are safe and common. Most participants in similar studies experience only minor discomfort from the fingerstick. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare the performance of two blood tests for potassium and ionized calcium using a new approach. Unlike standard blood tests that typically use venous blood samples, this method uses capillary whole blood collected from a simple fingerstick. This could make the testing process easier and more convenient for patients, potentially leading to faster and more accessible monitoring of these important electrolytes.

Who Is on the Research Team?

Manish Gupta, MS, MBA

Principal Investigator

Abbott Point of Care

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who need blood tests for potassium and ionized calcium levels. Specific eligibility criteria are not provided, so it's best to contact the study team for details on who can participate.

Inclusion Criteria

I am 18 years old or older.

Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)

Exclusion Criteria

Previous enrollment in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Testing

Performance comparison of potassium (K) and ionized calcium (iCa) tests using capillary whole blood specimens

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Blood draw

Trial Overview

The trial is testing the accuracy of blood tests using the i-STAT 1 System by comparing its results with those from another blood analysis system. Participants will have their blood drawn for this comparison.

How Is the Trial Designed?

Group I: Method comparison for K and iCa tests using capillary whole blood specimens. Experimental Treatment 1 Intervention

Performance comparison: Using results from capillary whole blood specimens collected from fingerstick(s) from each subject enrolled in the study, the performance between i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on i-STAT 1 analyzer and a comparator blood analysis system will be compared.

Who Is Running the Clinical Trial?

Abbott Point of Care

Lead Sponsor

Trials

13

Recruited

10,200+

Citations

1.

globalpointofcare.abbott

globalpointofcare.abbott/us/en/product-details/apoc/istat-cg8plus-test-cartridge.html

i-STAT CG8+ Test Cartridge

The i-STAT CG8+ cartridge is a unique combination assay with simultaneous rapid measurement of blood chemistries, gases, and hematology parameters.

2.

globalpointofcare.abbott

globalpointofcare.abbott/content/dam/ardx/globalpointofcare/apoc/support/i-stat-1/cti-ifu/english-us/ifu/765792-00D.pdf

i-STAT CG8+ Cartridge

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, ionized Calcium, ...

3.

accessdata.fda.gov

accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=185166

Class 2 Device Recall Abbott iSTAT CG8 - accessdata.fda.gov

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287618

Evaluation of Potassium (K) and Ionized Calcium (iCa) ...

Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with ...

5.

fsca.swissmedic.ch

fsca.swissmedic.ch/mep/api/publications/Vk_20201228_03/documents/6

Urgent Field Safety Notice

The i-STAT CG8+ cartridge contains eight measured tests (sodium, potassium, ionized calcium, pH, pCO2,. pO2, glucose and hematocrit) and the i- ...