NCT04819035

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

Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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).

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 Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management

Conditions

• Sepsis
• Adult Disease
• Severe Sepsis
• Emergency Department

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-17
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2021-03-26
• Last updated: 2022-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study