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

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ClinicalTrials.gov Identifier: NCT04353388
Recruitment Status : Completed
First Posted : April 20, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Beckman Coulter, Inc.

Study Description
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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
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
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Study Type : Observational
Actual Enrollment : 1139 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : February 3, 2020
Actual Primary Completion Date : July 17, 2020
Actual Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Potential reduction of Time to Antibiotics [ Time Frame: 12 hours after ED presentation ]
    Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated


Secondary Outcome Measures :
  1. Performance [ Time Frame: 12 hours after ED presentation ]
    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


Other Outcome Measures:
  1. Health & Economic Benefits for Time to Antibiotics - Simulated [ Time Frame: 12 hours after ED presentation ]
    Determine MDW's ability to potentially reduced hospital stay using a simulated economic model

  2. Health & Economic Benefits for Hospital Stay - Simulated [ Time Frame: 12 hours after ED presentation ]
    Determine MDW's ability to potentially reduced Hospital stay, if applicable, using a simulated economic model

  3. Health & Economic Benefits for Mortality - Simulated [ Time Frame: 12 hours after ED presentation ]
    Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model

  4. Health & Economic Benefits for ICU Stay - Simulated [ Time Frame: 12 hours after ED presentation ]
    Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353388


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Beckman Coulter, Inc.
Investigators
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Principal Investigator: Tiffany Osborn, MD Washington University School of Medicine
More Information
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Responsible Party: Beckman Coulter, Inc.
ClinicalTrials.gov Identifier: NCT04353388    
Other Study ID Numbers: C48392
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Emergencies
Disease Attributes
 Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome
Inflammation