Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University

Sepsis Clinical Trial

Official title:

Post Market Observational Study of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) and Potential Reduction in Time to Antibiotics - Washington University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353388
• Other study ID #: C48392
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: July 17, 2020

Study information

• Verified date: July 2020
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1139
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adult Disease
• Emergencies
• Emergency Department
• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Diagnostic Test:
• CBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement will be used to detect sepsis. Results will not be used to manage patients.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health & Economic Benefits for Time to Antibiotics - Simulated	Determine MDW's ability to potentially reduced hospital stay using a simulated economic model	12 hours after ED presentation
Other	Health & Economic Benefits for Hospital Stay - Simulated	Determine MDW's ability to potentially reduced Hospital stay, if applicable, using a simulated economic model	12 hours after ED presentation
Other	Health & Economic Benefits for Mortality - Simulated	Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model	12 hours after ED presentation
Other	Health & Economic Benefits for ICU Stay - Simulated	Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model	12 hours after ED presentation
Primary	Potential reduction of Time to Antibiotics	Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated	12 hours after ED presentation
Secondary	Performance	Validate MDW's ability to identify incidence of patients diagnosed as Sepsis vs Non-Sepsis, including SIRS and milder forms of infection (non-SIRS) meeting Sepsis EMR definition of >=2 SIRS criteria within 12 hours of ED presentation and any microbial testing collected within 24 hours of triage in the ED	12 hours after ED presentation