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Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities

NCT06953154 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2025-08-21

No results posted yet for this study

Summary

In patients with the aforementioned comorbidities, septic conditions are common and associated with high mortality rates. Early diagnosis, along with prompt and appropriate management, has become a major challenge for emergency departments. However, it is often difficult to determine whether sepsis is the primary factor behind clinical decompensation, especially in patients with complex comorbidities where symptoms may be nonspecific and overlap with other causes of deterioration. This diagnostic uncertainty complicates the timely initiation of targeted treatment, making the role of biomarkers even more crucial.

The measurement of sepsis biomarkers is widely used in clinical practice to enhance diagnostic accuracy, but there remains a need for a more reliable biomarker. A biomarker with higher sensitivity and negative predictive value (NPV) is essential for the early initiation of treatment. Several European and American studies have demonstrated the added value of MDW as an early predictor of sepsis in patients admitted to intensive care units, as well as its diagnostic performance when combined with the qSOFA score.

In the literature, the MDW threshold is established at 21.5, offering optimal diagnostic power with good sensitivity and specificity, supporting its clinical application and its approval by the United States Food and Drug Administration (FDA) and the European Conformity (CE).

In Tunisia, few studies have focused on the effectiveness of this non-invasive tool in septic patients in emergency settings and its reliability in this context, highlighting the relevance of our research.

Conditions

Interventions

DIAGNOSTIC_TEST

monocyte distribution width

We compare the measured value with the MDW threshold value already established in the literature and its correlation with the SOFA score, qSOFA, lactate, and PVI in terms of sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV).

Sponsors & Collaborators

  • Hôpital Universitaire Sahloul

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06953154 on ClinicalTrials.gov