Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

NCT04804306 | Completed FDA Device

• 1 other identifier: C01238
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis; Adult Disease; Emergency Department; Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance

  Within 12 hours from presentation to the emergency department

Other Outcomes (3)

• Health & Economic Benefits for Hospital Stay - Simulated

  Within 12 hours from presentation to the emergency department

• Health & Economic Benefits for Intensive Care Unit Stay - Simulated

  Within 12 hours from presentation to the emergency department

• Health & Economic Benefits for Mortality - Simulated

  Within 12 hours from presentation to the emergency department

Study Arms (1)

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)

Interventions

Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW) DEVICE

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

Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Sepsis; Disease; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Joseph Parrillo, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

• Keri Bicking, PharmD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: September 5, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)