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

Sponsor

Beckman Coulter, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04819035

Collaborator

(none)

127

Enrollment

Location

11.4

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis Adult Disease Severe Sepsis Emergency Department	Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)

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

Study Design

Study Type:

Observational

Actual Enrollment :

127 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital

Actual Study Start Date :

Jun 17, 2021

Actual Primary Completion Date :

May 30, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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) MDW measurement will be used to detect sepsis. Results will not be used to manage patients.

Arm

Intervention/Treatment

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)

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

Outcome Measures

Primary Outcome Measures

Potential reduction of Time to Antibiotics Ordered and Administered [Within 12 hours from presentation to the emergency department]
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

Secondary Outcome Measures

Performance [Within 12 hours from presentation to the emergency department]
Monocyte Distribution Width's [MDW] ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.

Other Outcome Measures

Health & Economic Benefits for Hospital Stay - Simulated [Within 12 hours from presentation to the emergency department]
Monocyte Distribution Width's [MDW] ability to reduce length of hospital stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
Health & Economic Benefits for Intensive Care Unit Stay - Simulated [Within 12 hours from presentation to the emergency department]
Monocyte Distribution Width's [MDW] ability to reduce length of intensive care unit stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.
Health & Economic Benefits for Mortality - Simulated [Within 12 hours from presentation to the emergency department]
Monocyte Distribution Width's [MDW] ability to reduce in-house mortality by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Methodist Hospital	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Beckman Coulter, Inc.

Investigators

Principal Investigator: Magdalena Czader, MD, Indiana University Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beckman Coulter, Inc.

ClinicalTrials.gov Identifier:

NCT04819035

Other Study ID Numbers:

C54020

First Posted:

Mar 26, 2021

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sepsis

Toxemia

Emergencies

Study Results

No Results Posted as of Jul 18, 2022