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

NCT04819035 | Completed FDA Device

• 1 other identifier: C54020
• Study Type: observational
• Target: 127
• 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; Severe Sepsis; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Potential reduction of Time to Antibiotics Ordered and Administered

  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

  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)

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)

Interventions

CBC-DIFF Monocyte Volume Width Distribution (MDW) DIAGNOSTIC_TEST

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

CBC-Diff Monocyte Volume Width Distribution

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• 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)

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, 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

• Magdalena Czader, MD

  Indiana University 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 24, 2021
• First Posted: March 26, 2021
• Study Start: June 17, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)