Clinical trial NCT03588325: Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
Official title: Evaluation of MDW for Early Detection of Sepsis In the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Infection
Sepsis
Severe Sepsis
Keywords: MDW
Sepsis
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults with suspicion of infection who present to the Emergency Department and for whom a CBC-DIFF is ordered upon presentation

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Identification of sepsis based on Sepsis-2 criteria
timeFrame: Within 4 hours of presentation
Secondary outcomes:
measure: Identification of sepsis based on Sepsis-3 criteria
timeFrame: Within 4 hours of presentation
Other outcomes:
Locations:
city: Paris
country: France
facility: La Pitié-Salpétrière
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Pierre Hausfater, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hausfater P, Robert Boter N, Morales Indiano C, Cancella de Abreu M, Marin AM, Pernet J, Quesada D, Castro I, Careaga D, Arock M, Tejidor L, Velly L. Monocyte distribution width (MDW) performance as an early sepsis indicator in the emergency department: comparison with CRP and procalcitonin in a multicenter international European prospective study. Crit Care. 2021 Jun 30;25(1):227. doi: 10.1186/s13054-021-03622-5.