Sepsis Prediction by Monocyte Distribution Width and Procalcitonin

NCT04322942 | Unknown FDA Device

• 1 other identifier: XPRPG3J0051
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

sepsis; procalcitonin; MDW

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Non-infection

Diagnostic Test: Monocyte Distribution Width

Infection without sepsis

Diagnostic Test: Monocyte Distribution Width

Sepsis-2

Diagnostic Test: Monocyte Distribution Width

Sepsis-3

Diagnostic Test: Monocyte Distribution Width

Interventions

Monocyte Distribution Width DIAGNOSTIC_TEST

Monocyte Distribution Width as part of the CBC result.

Infection without sepsis; Non-infection; Sepsis-2; Sepsis-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Medical Center

Taoyuan District, 新北市, 333, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 34983430 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chih-huang Li, MD

  Chang Gung Memorial Hospital, Linkou Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-huang Li, MD

CONTACT

0975360718; chhli2002@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: March 26, 2020
• Study Start: April 16, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

TW (1)