Clinical Evaluation of Precision for the Potassium and Ionized Calcium Tests in Capillary Specimens

NCT ID: NCT07287631

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-17

Study Completion Date

2026-12-31

Brief Summary

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Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.

Detailed Description

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The objective of this study is to assess the precision of the i-STAT K and iCa tests using the IUO i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from two separate capillary specimens from each subject enrolled in the study.

Conditions

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Hematologic Tests

Keywords

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Potassium (K) and ionized calcium (iCa)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Precision of potassium (K) and ionized calcium (iCa) tests in capillary blood

Precision evaluation of the i-STAT K test and the i-STAT iCa test using i-STAT CG8+ cartridge on i-STAT 1 analyzer with capillary specimens from each subject enrolled in the study.

Group Type OTHER

Capillary blood draw

Intervention Type DIAGNOSTIC_TEST

Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes.

Interventions

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Capillary blood draw

Capillary whole blood specimens collected from fingerstick(s) will be collected from each enrolled subject with blood collection capillary tubes.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Point of Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manish Gupta, MS, MBA

Role: STUDY_DIRECTOR

Abbott Point of Care

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status RECRUITING

Penn State Health Milton S. Hershey Medical Center (Hershey)

Hershey, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Miranda Gonzalez Aguirre, PhD

Role: CONTACT

Phone: 613-604-8539

Email: [email protected]

Facility Contacts

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Justin T Baca, MD, PhD

Role: primary

Michael H Creer, MD

Role: primary

Tom Aufderheide, MD

Role: primary

Other Identifiers

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CS-2025-0002

Identifier Type: -

Identifier Source: org_study_id