Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

Beckman Coulter

Status

Completed

Conditions

Severe Infection

Severe Sepsis

Sepsis

Treatments

Diagnostic Test: CBC-DIFF with MDW, PCT, CRP

Study type

Observational

Funder types

Industry

Identifiers

NCT03588325

C26841

Details and patient eligibility

About

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).

Full 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

Enrollment

947 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria