Status:

COMPLETED

Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital

Lead Sponsor:

Beckman Coulter, Inc.

Conditions:

Sepsis

Adult Disease

Eligibility:

All Genders

18-89 years

Brief Summary

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emerg...

Detailed Description

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis De...

Eligibility Criteria

Inclusion

  • Adult (18 to 89 years)
  • All race and ethnicities
  • Presenting to the emergency department with suspicion of infection
  • Whose assessment includes a CBC with differential
  • Meets EMR Sepsis Definition

Exclusion

  • Pregnancy
  • Prisoners
  • Transfers from other ED
  • Previously enrolled

Key Trial Info

Start Date :

June 17 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 30 2022

Estimated Enrollment :

127 Patients enrolled

Trial Details

Trial ID

NCT04819035

Start Date

June 17 2021

End Date

May 30 2022

Last Update

July 18 2022

Active Locations (1)

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Indiana University Methodist Hospital

Indianapolis, Indiana, United States, 46202