Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

Beckman Coulter

Status: Completed

Conditions: Emergency Department; Severe Sepsis; Adult Disease; Sepsis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04804306

C01238

Details and patient eligibility

About

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).

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 19 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

198 participants in 1 patient group

Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution

Description:

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

Treatment:

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