Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood

NCT ID: NCT06295835

Last Updated: 2025-03-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-01-29

Brief Summary

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Method comparison study for Potassium (K) and ionized calcium (iCa).

Detailed Description

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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.

Conditions

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Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Method comparison for K and iCa Tests using capillary whole blood specimens.

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.

Group Type OTHER

Fingerstick blood draw

Intervention Type DIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingersticks.

Interventions

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Fingerstick blood draw

Capillary blood specimen collected from two separate fingersticks.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Signed and dated consent form (if required by the IRB)
* ≥ 18 years of age

Exclusion Criteria

• Prior enrollment in the 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, BS, MBA

Role: STUDY_DIRECTOR

Abbott Point of Care

Locations

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University of Maryland (UMD)

Baltimore, Maryland, United States

Site Status

Penn State University Hershey Medical Center (Hershey)

Hershey, Pennsylvania, United States

Site Status

Eastside Research Associates (ERA)

Redmond, Washington, United States

Site Status

Abbott Point of Care (APOC)

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CS-2024-0001

Identifier Type: -

Identifier Source: org_study_id

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