Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

Study Overview
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Brief Summary
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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).

Detailed Description
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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

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

Conditions
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Severe Infection, Sepsis, Severe Sepsis

Intervention / Treatment
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* Diagnostic Test: CBC-DIFF with MDW, PCT, CRP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CBC-DIFF with MDW, PCT, CRP|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of sepsis based on Sepsis-2 criteria | 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 | Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves | Within 4 hours of presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDW, Sepsis