Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples

March 16, 2018 updated by: Abbott Point of Care

Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium

The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentucky Clinical Trials Laboratory
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults (18 years or older)

Description

Inclusion Criteria:

  • Subject is ≥ 18 years of age
  • Subjects (or their legal representative) who are willing to voluntarily consent to the study

Exclusion Criteria:

  • There are no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose (mg/dL) levels
Time Frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Patient's blood is tested within 3 minutes of blood collection
Hematocrit (%PCV) levels
Time Frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Patient's blood is tested within 3 minutes of blood collection
Sodium (mmol/L) levels
Time Frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Patient's blood is tested within 3 minutes of blood collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Point of Care

Investigators

  • Study Director: Chris P Edwards, BSc, Abbott Point of Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

March 15, 2017

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CS-2016-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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