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

Last updated: August 20, 2025
Sponsor: Hôpital Universitaire Sahloul
Overall Status: Completed

Phase

N/A

Condition

Soft Tissue Infections

Treatment

monocyte distribution width

Clinical Study ID

NCT06953154
Emergency Department
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged over 18 years admitted to the emergency department for decompensationof congestive heart failure or renal failure, or exacerbation of COPD.

Exclusion

Exclusion Criteria:

  • Patients who received antibiotic treatment in the past 7 days, pregnant women,children, non-consenting patients, patients with a history of malignant hematologicdisease, polytransfused patients or those who recently received a transfusion, andpatients whose MDW was not reported due to ineffective monocyte counting.

Study Design

Total Participants: 325
Treatment Group(s): 1
Primary Treatment: monocyte distribution width
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
June 30, 2025

Study Description

We will test the effectiveness of MDW in the early diagnosis of sepsis as a factor of decompensation in patients with comorbidities: renal failure, heart failure, and COPD.

Connect with a study center

  • Sahloul University Hospital

    Sousse, 4021
    Tunisia

    Site Not Available

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