Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

NCT ID: NCT04322942

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2020-09-30

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.

Conditions

Sepsis; Diagnoses Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Non-infection

Monocyte Distribution Width

Intervention Type: DIAGNOSTIC_TEST

Monocyte Distribution Width as part of the CBC result.

Infection without sepsis

Monocyte Distribution Width

Intervention Type: DIAGNOSTIC_TEST

Monocyte Distribution Width as part of the CBC result.

Sepsis-2

Monocyte Distribution Width

Intervention Type: DIAGNOSTIC_TEST

Monocyte Distribution Width as part of the CBC result.

Sepsis-3

Monocyte Distribution Width

Intervention Type: DIAGNOSTIC_TEST

Monocyte Distribution Width as part of the CBC result.

Interventions

Monocyte Distribution Width

Monocyte Distribution Width as part of the CBC result.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-huang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Linkou Medical Center

Locations

Chang Gung Memorial Hospital, Linkou Medical Center

Taoyuan District, 新北市, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-huang Li, MD

Role: CONTACT

chhli2002@gmail.com

0975360718

Facility Contacts

Chih-huang Li

Role: primary

chhli2002@gmail.com

0975360718

References

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.

Reference Type: DERIVED

PMID: 34983430 (View on PubMed)

Other Identifiers

XPRPG3J0051

Identifier Type: -

Identifier Source: org_study_id