Precision Study Measuring Potassium (K) in Capillary Specimens

NCT ID: NCT06291493

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

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2024-09-13

Brief Summary

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Assessing precision of i-STAT K test using the IUO 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 test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.

Conditions

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Precision of Potassium (K) Test in Capillary Whole Blood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Capillary precision analysis will be performed for Potassium K.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Precision assessment of Potassium (K) test in capillary blood sample

Prospectively collected capillary specimens from two separate fingerstick blood draws.

Group Type OTHER

Fingerstick blood draw

Intervention Type DIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingerstick blood draws.

Interventions

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Fingerstick blood draw

Capillary blood specimen collected from two separate fingerstick blood draws.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Blood draw

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, Baltimore (UMD)

Baltimore, Maryland, United States

Site Status

Penn State Health Milton S. 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-2024-0002

Identifier Type: -

Identifier Source: org_study_id

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