SepsisMDWNCT06953154
Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities
An observational study of Sepsis, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- monocyte distribution width
- How many people
- 325 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with comorbidities (heart failure , renal failure and COPD)
Who may be able to join
- Patients aged over 18 years admitted to the emergency department for decompensation of congestive heart failure or renal failure, or exacerbation of COPD.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- monocyte distribution width
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monocyte distribution widthDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death and readmission
Measured: 30 days
Secondary outcomes (1)
Correlation of MDW with SOFA and other sepsis markers (lactate, PVI, and procalcitonin)
Measured: 01 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Dec 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953154
- Sponsor's protocol ID
- Emergency Department
- Acronym
- MDW
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocyte Distribution Width (MDW): An Early Marker of Sepsis in Patients With Comorbidities
- ClinicalTrials.gov ID
- NCT06953154
- Acronym / sponsor ID
- MDW / Emergency Department
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with comorbidities (heart failure , renal failure and COPD)
Key inclusion criteria (1 listed)
- Patients aged over 18 years admitted to the emergency department for decompensation of congestive heart failure or renal failure, or exacerbation of COPD.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monocyte distribution widthWe 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). | Diagnostic test | – |
Primary outcome
composite of death and readmission
Time frame: 30 days
1 secondary outcome
Correlation of MDW with SOFA and other sepsis markers (lactate, PVI, and procalcitonin)
Time frame: 01 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death and readmission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.