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

Completed

Conditions studied: Sepsis, Adult Disease, Severe Sepsis, Emergency Department

In brief

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 Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

Key facts

Study ID

NCT04819035

Run by

Beckman Coulter, Inc.

People needed

127

Starts

2021-06-17

Expected to finish

2022-05-30

Last updated by the study team

2022-07-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Indiana University Methodist Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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