Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W

Completed

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

• Registration Number: NCT04291417
• 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 Start: 2019-11-20
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Primary Completion: 2020-05-14
• Study Completion: 2020-06-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1700

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

Primary Outcome Measures

Name	Time	Method
Potential reduction of Time to Antibiotics	12 hrs after ED presentation	Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated

Secondary Outcome Measures

Name	Time	Method
Performance	12 hrs after ED presentation	Validate MDW's ability to identify incidence of patients diagnosed as Sepsis vs Non-Sepsis, including SIRS and milder forms of infection (non-SIRS) meeting Sepsis EMR definition of \>=2 SIRS criteria within 12 hours of ED presentation and any microbial testing collected within 24 hours of triage in the ED

Trial Locations

Locations (1)

Baylor Scott & White MEdical Center; 🇺🇸 Temple, Texas, United States