Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

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

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: Device: 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): 198

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• 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:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution; MDW measurement used to detect sepsis as part of the CBC-Diff ordered by ED Physician as part of the Institution's Standard of Care. Results will not be used to manage patients	Device: Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW); MDW measurement 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	MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated	Within 12 hours from presentation to the emergency department

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	MDW's ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition	Within 12 hours from presentation to the emergency department

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health & Economic Benefits for Hospital Stay - Simulated	MDW's ability to reduce length of hospital stay	Within 12 hours from presentation to the emergency department
Health & Economic Benefits for Intensive Care Unit Stay - Simulated	MDW's ability to reduce length of intensive care unit stay	Within 12 hours from presentation to the emergency department
Health & Economic Benefits for Mortality - Simulated	MDW's ability to reduce in-house mortality	Within 12 hours from presentation to the emergency department

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.
• Investigators: Principal Investigator: Joseph Parrillo, MD, Hackensack Meridian Health; Principal Investigator: Keri Bicking, PharmD, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

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: C01238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes