Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

Comparison of the Diagnostic Accuracy of Monocyte Distribution Width and Procalcitonin on Sepsis in the Emergency Department

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Diagnoses Disease
• Intervention / Treatment: Diagnostic test: Monocyte Distribution Width

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Chih-huang Li, MD; Phone Number: 0975360718; Email: chhli2002@gmail.com

Study Locations

• Taiwan
  • 新北市
    • Taoyuan, 新北市, Taiwan, 333
      • Recruiting
      • Chang Gung Memorial Hospital, Linkou Medical Center
      • Contact: Chih-huang Li; Phone Number: 0975360718; Email: chhli2002@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-infection	Diagnostic test: Monocyte Distribution Width; Monocyte Distribution Width as part of the CBC result.
Infection without sepsis	Diagnostic test: Monocyte Distribution Width; Monocyte Distribution Width as part of the CBC result.
Sepsis-2	Diagnostic test: Monocyte Distribution Width; Monocyte Distribution Width as part of the CBC result.
Sepsis-3	Diagnostic test: Monocyte Distribution Width; Monocyte Distribution Width as part of the CBC result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of predicting sepsis and sepsis-3 patients	MDW, PCT, and other laboratory tests were all obtained at the same time with 2 hours after the patient was admitted to the emergency department (ED). Sensitivity and specificity of different cutoff value were calculated. Best cutoff value will be decided by the perfomance.	within 2 hours after patient arrived ED.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chih-huang Li, MD, Chang Gung Memorial Hospital, Linkou Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: March 22, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: sepsis; procalcitonin; MDW
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: XPRPG3J0051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No