Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W

Sponsor
Beckman Coulter, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04291417
Collaborator
(none)
1,700
1
6.9
246.4

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
  • 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 :
1700 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 - Baylor Scott & White Medical Center
Actual Study Start Date :
Nov 20, 2019
Actual Primary Completion Date :
May 14, 2020
Actual Study Completion Date :
Jun 17, 2020

Arms and Interventions

Arm Intervention/Treatment
CBC-Diff Monocyte Volume Width Distribution

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

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

Outcome Measures

Primary Outcome Measures

  1. Potential reduction of Time to Antibiotics [12 hrs 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 [12 hrs 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 [12 hrs 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 [12 hrs after ED presentation]

    Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model.

  3. Health & Economic Benefits for Mortality - Simulated [12 hrs after ED presentation]

    Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 Baylor Scott & White MEdical Center Temple Texas United States 76508

Sponsors and Collaborators

  • Beckman Coulter, Inc.

Investigators

  • Principal Investigator: Amin A Mohammad, Ph. D, Baylor Scott & White Medical Center, Temple

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beckman Coulter, Inc.
ClinicalTrials.gov Identifier:
NCT04291417
Other Study ID Numbers:
  • C47940
First Posted:
Mar 2, 2020
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
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.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2021