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

Completed

• Conditions: Sepsis; Emergency Department; Adult Disease; Severe Sepsis
• Interventions: Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)

• Registration Number: NCT04819035
• Lead Sponsor: Beckman Coulter, Inc.

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 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

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Study Start: 2021-06-17
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• 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 Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CBC-Diff Monocyte Volume Width Distribution	CBC-DIFF Monocyte Volume Width Distribution (MDW)	Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential

Primary Outcome Measures

Name	Time	Method
Potential reduction of Time to Antibiotics Ordered and Administered	Within 12 hours from presentation to the emergency department	Monocyte Distribution Width's \[MDW\] ability to reduce time to first antibiotics ordered by physician (decision to treat) and first antibiotics administered via a simulation

Secondary Outcome Measures

Name	Time	Method
Performance	Within 12 hours from presentation to the emergency department	Monocyte Distribution Width's \[MDW\] ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.

Trial Locations

Locations (1)

Indiana University Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States