Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588325
• Other study ID #: C26841
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: August 30, 2019
• Est. primary completion date: August 2, 2019
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Infection
• Severe Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
France	La Pitié-Salpétrière	Paris
Spain	Hospital Universitari Germans Trias I Pujol	Badalona

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of sepsis based on Sepsis-2 criteria	Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves	Within 4 hours of presentation
Secondary	Identification of sepsis based on Sepsis-3 criteria	Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves	Within 4 hours of presentation