Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

NCT03588325 | Completed

• 1 other identifier: C26841
• Study Type: observational
• Target: 947
• Locations: 2 countries
• Sites: 2

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).

Conditions

Severe Infection; Sepsis; Severe Sepsis

Keywords

MDW; Sepsis

Outcome Measures

Primary Outcomes (1)

• Identification of sepsis based on Sepsis-2 criteria

  Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves

  Within 4 hours of presentation

Secondary Outcomes (1)

• Identification of sepsis based on Sepsis-3 criteria

  Within 4 hours of presentation

Interventions

CBC-DIFF with MDW, PCT, CRP DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• CBC-DIFF upon presentation
• Adults (18-89) of all races \& ethnicities
• Signed Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead

Study Sites (2)

La Pitié-Salpétrière

Paris, 75651, France

Location

Hospital Universitari Germans Trias I Pujol

Badalona, 08910, Spain

Location

Related Publications (1)

• 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.

  PMID: 34193208 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples from LPS to be stored frozen for subsequent testing for sepsis biomarkers

MeSH Terms

Conditions

Infections; Sepsis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Hausfater, MD

  Groupe Hospitalier Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 17, 2018
• Study Start: August 8, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 30, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

FR (1); ES (1)