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Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Unknown

Conditions

Diagnoses Disease
Sepsis

Treatments

Diagnostic Test: Monocyte Distribution Width

Study type

Observational

Funder types

Other

Identifiers

NCT04322942
XPRPG3J0051

Details and patient eligibility

About

The mortality rate of sepsis remains as high as 30 to 40%. Early diagnosis and treatment of patients with sepsis reduce mortality significantly. The most commonly used biomarkers in clinical practice are C-reactive protein (CRP) and procalcitonin (PCT). In terms of exploring new diagnostic tools of sepsis, monocyte distribution width (MDW) was first reported in 2017. It was reported as part of the white blood cell (WBC) differential count. MDW greater than 20 and abnormal WBC count together were reported to provide a satisfactory accuracy. The area under curve (AUC) in predicting sepsis-2 is 0.852. It was proposed as a novel diagnostic tool of sepsis in the emergency setting. Nonetheless, the performance of MDW compared with the conventional biomarkers remained unknown. The aim of this study was to compare the diagnostic accuracy of MDW and PCT on sepsis in the emergency department.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Subject Inclusion Criteria

  • Adult ≥20 years) subjects presenting to the ED with the chief complaints of fever, altered consciousness, hypotension, and dyspnea. CBC with differential testing performed, at presentation as part of their standard medical care.
  • Subjects who have signed Informed Consent.

Subject Exclusion Criteria

  • Previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
  • Subjects discharged from the ED <72 hours
  • Pregnant women
  • Subjects not able to understand or sign Informed Consent

Trial design

600 participants in 4 patient groups

Non-infection
Treatment:
Diagnostic Test: Monocyte Distribution Width
Infection without sepsis
Treatment:
Diagnostic Test: Monocyte Distribution Width
Sepsis-2
Treatment:
Diagnostic Test: Monocyte Distribution Width
Sepsis-3
Treatment:
Diagnostic Test: Monocyte Distribution Width

Trial contacts and locations

1

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Central trial contact

Chih-huang Li, MD

Data sourced from clinicaltrials.gov

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