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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Severe Infection
• Intervention / Treatment: Diagnostic test: CBC-Diff Monocyte volume width distribution (MDW)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All adult patients with suspicion who present to ED and for whom CBC with Diff is performed upon ED presentation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2)	Determination of the diagnostic accuracy, area under the receiver operating characteristic curve	12 hours after presentation to the ED

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.

Publications and helpful links

General Publications

• Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: C03747