Clinical trial NCT04322942: Sepsis Prediction by Monocyte Distribution Width and Procalcitonin
Official title: Comparison of the Diagnostic Accuracy of Monocyte Distribution Width and Procalcitonin on Sepsis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Diagnoses Disease
Keywords: sepsis
procalcitonin
MDW
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Based on a target of 75% sensitivity and lower limit of 65%, a minimum of 63 (will target 100) septic patients would be required. Higher numbers may be enrolled in the study to ensure adequate representation of sepsis cases. Given the estimated prevalence of the disease in the emergency department population (5-10%%), the number of non-septic patients is predicted to be significantly higher than septic. Based on the estimated prevalence of subjects who present and have blood draw, a minimum of 100 non-septic cases will be collected.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Sensitivity and specificity of predicting sepsis and sepsis-3 patients
timeFrame: within 2 hours after patient arrived ED.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou Medical Center
state: 新北市
Study officials:
affiliation: Chang Gung Memorial Hospital, Linkou Medical Center
name: Chih-huang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li CH, Seak CJ, Chaou CH, Su TH, Gao SY, Chien CY, Ng CJ. Comparison of the diagnostic accuracy of monocyte distribution width and procalcitonin in sepsis cases in the emergency department: a prospective cohort study. BMC Infect Dis. 2022 Jan 4;22(1):26. doi: 10.1186/s12879-021-06999-4.