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

Completed

• Conditions: Severe Infection; Sepsis

• Registration Number: NCT03145428
• Lead Sponsor: Beckman Coulter, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-06-19
• Primary Completion: 2017-12-22
• Study Completion: 2018-01-26
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (3)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States