Testing potassium and ionized calcium from fingerstick blood using the i-STAT CG8+ system
Clinical Evaluation of Precision for the Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
NA · Abbott Point of Care · NCT07287631
This project tests if the i-STAT CG8+ cartridge gives precise potassium and ionized calcium results from fingerstick (capillary) blood in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Point of Care (industry) |
| Locations | 3 sites (Albuquerque, New Mexico and 2 other locations) |
| Trial ID | NCT07287631 on ClinicalTrials.gov |
What this trial studies
The study collects two separate capillary blood specimens from each adult participant and runs potassium and ionized calcium measurements on the investigational-use-only i-STAT CG8+ cartridge with the i-STAT 1 analyzer. Precision will be quantified by comparing repeated capillary measurements to determine within-run and between-sample reproducibility. Enrollment occurs at three U.S. academic centers and involves a single capillary blood draw session per participant. Findings will help determine whether capillary i-STAT measurements are reliably precise for point-of-care use.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent and provide two capillary (fingerstick) blood samples are eligible to participate.
Not a fit: People under 18, those unable to consent or unable to provide capillary samples, and patients expecting direct therapeutic benefit are unlikely to receive clinical benefit from participation.
Why it matters
Potential benefit: If successful, this could make fingerstick potassium and ionized calcium testing more reliable at the bedside, speeding decision-making for clinicians.
How similar studies have performed: Previous evaluations of i-STAT point-of-care analyzers have generally shown good agreement with laboratory electrolyte measurements, though capillary potassium and ionized calcium precision has been less extensively characterized and is the focus here.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB) 2. ≥ 18 years of age Exclusion Criteria: 1\. Previous enrollment in this study
Where this trial is running
Albuquerque, New Mexico and 2 other locations
- University of New Mexico — Albuquerque, New Mexico, United States (RECRUITING)
- Penn State Health Milton S. Hershey Medical Center (Hershey) — Hershey, Pennsylvania, United States (NOT_YET_RECRUITING)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Miranda Gonzalez Aguirre, PhD
- Email: miranda.gonzalezaguirre@abbott.com
- Phone: 613-604-8539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Tests, Potassium and ionized calcium