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

NCT04819035 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2022-07-18

No results posted yet for this study

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 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).

Conditions

  • Sepsis
  • Adult Disease
  • Severe Sepsis
  • Emergency Department

Interventions

DIAGNOSTIC_TEST

CBC-DIFF Monocyte Volume Width Distribution (MDW)

MDW measurement will be used to detect sepsis. Results will not be used to manage patients.

Sponsors & Collaborators

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • Magdalena Czader, MD · Indiana University Health

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2022-05-30
Completion
2022-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819035 on ClinicalTrials.gov