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

Sepsis Clinical Trial

— MDW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145428
• Other study ID #: C03747
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: January 26, 2018

Study information

• Verified date: November 2019
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 26, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Infection
• Toxemia

Intervention

Diagnostic Test:
• CBC-Diff Monocyte volume width distribution (MDW)
MDW measurement used to detect sepsis. Results will not be used to manage patients

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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