Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University

Post Market Observational Study of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) and Potential Reduction in Time to Antibiotics - Washington University

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).

Study Overview

• Status: Completed
• Conditions: Sepsis; Severe Sepsis; Emergency Department; Adult Disease
• Intervention / Treatment: Diagnostic test: CBC-DIFF Monocyte Volume Width Distribution (MDW)

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 Type: Observational
• Enrollment (Actual): 1139

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care

Description

Inclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CBC-Diff Monocyte Volume Width Distribution; Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential reduction of Time to Antibiotics	Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated	12 hours after ED presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	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	12 hours after ED presentation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health & Economic Benefits for Time to Antibiotics - Simulated	Determine MDW's ability to potentially reduced hospital stay using a simulated economic model	12 hours after ED presentation
Health & Economic Benefits for Hospital Stay - Simulated	Determine MDW's ability to potentially reduced Hospital stay, if applicable, using a simulated economic model	12 hours after ED presentation
Health & Economic Benefits for Mortality - Simulated	Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model	12 hours after ED presentation
Health & Economic Benefits for ICU Stay - Simulated	Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model	12 hours after ED presentation

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2020
• Primary Completion (ACTUAL): July 17, 2020
• Study Completion (ACTUAL): July 17, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (ACTUAL): April 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: C48392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No