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NCT Number: NCT03145428

Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Infection Systemic Inflammatory Response Syndrome

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hackensack University Medical Center, Hackensack, New Jersey, United States

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About this study

A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults (18-89 years) presenting to ED
  • All races & ethnicities
  • CBC with Differential performed upon presentation
  • Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)

Exclusion criteria

  • Previously enrolled
  • Subjects discharged <12 hours form ED presentation

Treatment and study plan

CBC-Diff Monocyte volume width distribution (MDW)

Diagnostic Test

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

Primary outcomes

  1. Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2)

    Time frame: 12 hours after presentation to the ED

    Determination of the diagnostic accuracy, area under the receiver operating characteristic curve

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer

Acronym: MDW

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 9, 2017
Registry last updated
Nov 22, 2019

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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