NCT03588325

Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 947 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

Summary

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

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

Conditions

• Severe Infection
• Sepsis
• Severe Sepsis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-08
• Primary completion: 2019-08-02
• Completion: 2019-08-30
• First posted: 2018-07-17
• Last updated: 2019-11-22

Locations

2 sites across 2 countries: France, Spain