Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267742
• Other study ID #: CHN097
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Beckman Coulter, Inc.
• Contact: DI HOU, Ph.D
• Phone: +861065213000
• Email: dhou01[@]beckman.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Complete Blood Count (CBC) with Differential
CBC with Differential including Monocyte Distribution Width (MDW)

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital, Sichuan University	Chengdu
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou

Sponsors (4)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.	Peking Union Medical College Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity, specificity	sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2	2022.3-2024.3