Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis
MDW
1 other identifier
observational
3,000
1 country
3
Brief Summary
The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedStudy Start
First participant enrolled
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedNovember 22, 2019
November 1, 2019
6 months
May 4, 2017
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2)
Determination of the diagnostic accuracy, area under the receiver operating characteristic curve
12 hours after presentation to the ED
Interventions
MDW measurement used to detect sepsis. Results will not be used to manage patients
Eligibility Criteria
All adult patients with suspicion who present to ED and for whom CBC with Diff is performed upon ED presentation.
You may qualify if:
- Adults (18-89 years) presenting to ED
- All races \& ethnicities
- CBC with Differential performed upon presentation
- Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)
You may not qualify if:
- Previously enrolled
- Subjects discharged \<12 hours form ED presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020.
PMID: 32391157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 9, 2017
Study Start
June 19, 2017
Primary Completion
December 22, 2017
Study Completion
January 26, 2018
Last Updated
November 22, 2019
Record last verified: 2019-11