Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

November 21, 2019 updated by: Beckman Coulter, Inc.

Evaluation of MDW for Early Detection of Sepsis In the Emergency Department

The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To confirm the clinical validity and performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC with Differential ordered upon ED presentation. Septic patients are identified as those with values equal to or above the MDW threshold and non-septic patients are those with MDW values below the threshold. As the anticoagulant used at the sites is K3EDTA, the cut-off value will be assessed using sepsis cases and all corresponding non-sepsis to confirm optimal cut-off.

To explore the added value of this parameter in a patient diagnostic pathway that includes the use of procalcitonin (PCT) or C reactive protein (CRP) for the identification of septic patients All enrolled subjects will have PCT/ CRP assay performed per protocol Plasma will be aliquot and stored frozen for subsequent testing at Beckman Coulter for other sepsis biomarker tests (additional PCT& CRP tests and interleukin-6 (IL-6) on the sponsor's devices

Study Type

Observational

Enrollment (Actual)

947

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75651
        • La Pitié-Salpêtrière
  • Spain
      • Badalona, Spain, 08910
        • Hospital Universitari Germans Trias I Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adults with suspicion of infection who present to the Emergency Department and for whom a CBC-DIFF is ordered upon presentation

Description

Inclusion Criteria:

  • CBC-DIFF upon presentation
  • Adults (18-89) of all races & ethnicities
  • Signed Informed Consent

Exclusion Criteria:

  • Previously enrolled
  • Incomplete Informed Consent
  • Subject discharged <4 hours from presentation
  • PCT or CRP not performed per protocol
  • Pregnancy
  • Prisoners
  • Subjects Under Custody or Guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 based on Sepsis-2 criteria
Time Frame: Within 4 hours of presentation
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Within 4 hours of presentation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of sepsis based on Sepsis-3 criteria
Time Frame: Within 4 hours of presentation
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Within 4 hours of presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Investigators

  • Principal Investigator: Pierre Hausfater, MD, Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

August 2, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 17, 2018

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C26841

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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