Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322942
• Other study ID #: XPRPG3J0051
• Status: Recruiting
• Start date: April 16, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2020
• Source: Chang Gung Memorial Hospital
• Contact: Chih-huang Li, MD
• Phone: 0975360718
• Email: chhli2002[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Monocyte Distribution Width
Monocyte Distribution Width as part of the CBC result.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou Medical Center	Taoyuan	???

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.