An observational study in Severe Infection, Sepsis and Severe Sepsis, sponsored by Beckman Coulter, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Beckman Coulter, Inc. · Observational
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).
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
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 947 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All adults with suspicion of infection who present to the Emergency Department and for whom a CBC-DIFF is ordered upon presentation
Exclusion Criteria:
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
Identification of sepsis based on Sepsis-2 criteria
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Time frame: Within 4 hours of presentation
Identification of sepsis based on Sepsis-3 criteria
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Time frame: Within 4 hours of presentation
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Beckman Coulter, Inc.