Clinical trial NCT04819035: Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital
Official title: Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Adult Disease
Severe Sepsis
Emergency Department
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care

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).

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

Eligibility criteria: 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

Primary outcomes:
measure: Potential reduction of Time to Antibiotics Ordered and Administered
timeFrame: Within 12 hours from presentation to the emergency department
Secondary outcomes:
measure: Performance
timeFrame: Within 12 hours from presentation to the emergency department
Other outcomes:
measure: Health & Economic Benefits for Hospital Stay - Simulated
timeFrame: Within 12 hours from presentation to the emergency department
measure: Health & Economic Benefits for Intensive Care Unit Stay - Simulated
timeFrame: Within 12 hours from presentation to the emergency department
measure: Health & Economic Benefits for Mortality - Simulated
timeFrame: Within 12 hours from presentation to the emergency department
Locations:
city: Indianapolis
country: United States
facility: Indiana University Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University Health
name: Magdalena Czader, MD
role: PRINCIPAL_INVESTIGATOR
References: