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

August 20, 2025 updated by: Riadh Boukef, Hôpital Universitaire Sahloul

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4021
        • Sahloul University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite of death and readmission
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of MDW with SOFA and other sepsis markers (lactate, PVI, and procalcitonin)
Time Frame: 01 day
01 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Universitaire Sahloul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Emergency Department

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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