Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

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).

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

La Pitié-Salpétrière, Paris, France

About this study

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

Who can participate

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

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

Treatment and study plan

CBC-DIFF with MDW, PCT, CRP

Diagnostic Test

Tests will be run to determine early identification of sepsis and added value of the combination of tests. Results will not be used to manage patients

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 17, 2018
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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Completed