Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

Study Overview
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Brief Summary
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The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). In terms of exploring new diagnostic tools of sepsis, monocyte distribution width (MDW) was first reported in 2017. It was reported as part of the white blood cell (WBC) differential count. MDW greater than 20 and abnormal WBC count together were reported to provide a satisfactory accuracy. The area under curve (AUC) in predicting sepsis-2 is 0.852. It was proposed as a novel diagnostic tool of sepsis in the emergency setting. Nonetheless, the performance of MDW compared with the conventional biomarkers remained unknown. The aim of this study was to compare the diagnostic accuracy of MDW and PCT on sepsis in the emergency department.

Official Title
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Comparison of the Diagnostic Accuracy of Monocyte Distribution Width and Procalcitonin on Sepsis in the Emergency Department

Conditions
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Sepsis, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Monocyte Distribution Width


Participation Criteria
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Eligibility Criteria
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Subject Inclusion Criteria Adult ≥20 years) subjects presenting to the ED with the chief complaints of fever, altered consciousness, hypotension, and dyspnea. CBC with differential testing performed, at presentation as part of their standard medical care. Subjects who have signed Informed Consent. Subject Exclusion Criteria Previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study) Subjects discharged from the ED <72 hours Pregnant women Subjects not able to understand or sign Informed Consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-infection<br> | Diagnostic Test: Monocyte Distribution Width<br>* Monocyte Distribution Width as part of the CBC result.<br>|
| Infection without sepsis<br> | Diagnostic Test: Monocyte Distribution Width<br>* Monocyte Distribution Width as part of the CBC result.<br>|
| Sepsis-2<br> | Diagnostic Test: Monocyte Distribution Width<br>* Monocyte Distribution Width as part of the CBC result.<br>|
| Sepsis-3<br> | Diagnostic Test: Monocyte Distribution Width<br>* Monocyte Distribution Width as part of the CBC result.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of predicting sepsis and sepsis-3 patients | MDW, PCT, and other laboratory tests were all obtained at the same time with 2 hours after the patient was admitted to the emergency department (ED). Sensitivity and specificity of different cutoff value were calculated. Best cutoff value will be decided by the perfomance. | within 2 hours after patient arrived ED. | 

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