NCT02897154

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

July 6, 2016

Last Update Submit

March 16, 2018

Conditions

Analytical Performance of Sodium, Glucose and Hematocrit Assays by the i-STAT 500 (Alinity) Analyzer

Outcome Measures

Primary Outcomes (3)

  • Glucose (mg/dL) levels

    Data analysis

    Patient's blood is tested within 3 minutes of blood collection

  • Hematocrit (%PCV) levels

    Data analysis

    Patient's blood is tested within 3 minutes of blood collection

  • Sodium (mmol/L) levels

    Data analysis

    Patient's blood is tested within 3 minutes of blood collection

Interventions

In-vitroDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (18 years or older)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Kentucky Clinical Trials Laboratory

Louisville, Kentucky, 40202, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

In Vitro Meat

Intervention Hierarchy (Ancestors)

MeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chris P Edwards, BSc

    Abbott Point of Care

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

September 13, 2016

Study Start

May 10, 2016

Primary Completion

March 15, 2017

Study Completion

March 15, 2017

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)