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

NCT06953154 | Completed DMC

• 1 other identifier: Emergency Department
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Outcome Measures

Primary Outcomes (1)

• composite of death and readmission

  30 days

Secondary Outcomes (1)

• Correlation of MDW with SOFA and other sepsis markers (lactate, PVI, and procalcitonin)

  01 day

Interventions

monocyte distribution width DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with comorbidities (heart failure , renal failure and COPD)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

Sahloul University Hospital

Sousse, 4021, Tunisia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: service chief

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 1, 2025
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)