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NCT Number: NCT06267742

Clinical Trial to Evaluate MDW for Early Detection of Sepsis

This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, Beijing, China

Loading trial locations.

About this study

To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("CBC with differential") in the ED.

To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (18-89 years) presenting to ED.
  • CBC with Differential performed upon presentation as part of standard of care.
  • Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit
  • Signed the informed consent form

Exclusion criteria

  • Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed).
  • The subject is discharged from the hospital within 12 hours after ED visit

Treatment and study plan

Complete Blood Count (CBC) with Differential

Diagnostic Test

CBC with Differential including Monocyte Distribution Width (MDW)

Primary outcomes

  1. sensitivity, specificity

    Time frame: 2022.3-2024.3

    sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Collaborators

  • Peking Union Medical College Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • West China Hospital

Registry information

Official study title

Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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