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OpenTrials
Completed

NCT Number: NCT04804306

Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

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).

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Key information

Conditions

Sepsis Adult Disease Disease Disease Attributes Emergencies Emergency Department Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Sepsis Systemic Inflammatory Response Syndrome

Age range

19 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)

Device

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

Primary outcomes

  1. Potential reduction of Time to Antibiotics

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated

Secondary outcomes

  1. Performance

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition

Other outcomes

  1. Health & Economic Benefits for Hospital Stay - Simulated

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to reduce length of hospital stay

  2. Health & Economic Benefits for Intensive Care Unit Stay - Simulated

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to reduce length of intensive care unit stay

  3. Health & Economic Benefits for Mortality - Simulated

    Time frame: Within 12 hours from presentation to the emergency department

    MDW's ability to reduce in-house mortality

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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