NCT06291493

Brief Summary

Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

February 26, 2024

Last Update Submit

March 17, 2025

Conditions

Precision of Potassium (K) Test in Capillary Whole Blood

Outcome Measures

Primary Outcomes (1)

  • Precision for Potassium (K) Test

    Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer

    Up to 5 minutes

Study Arms (1)

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

OTHER

Prospectively collected capillary specimens from two separate fingerstick blood draws.

Diagnostic Test: Fingerstick blood draw

Interventions

Fingerstick blood drawDIAGNOSTIC_TEST

Capillary blood specimen collected from two separate fingerstick blood draws.

Also known as: Blood draw
Precision assessment of Potassium (K) test in capillary blood sample

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Maryland, Baltimore (UMD)

Baltimore, Maryland, 21201, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

Eastside Research Associates (ERA)

Redmond, Washington, 98052, United States

Location

Abbott Point of Care (APOC)

Ottawa, Ontario, K2H 8V4, Canada

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Manish Gupta, BS, MBA

    Abbott Point of Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Capillary precision analysis will be performed for Potassium K.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

May 7, 2024

Primary Completion

September 13, 2024

Study Completion

September 13, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)CA(1)