SepsisMDWNCT07350785
Prediction of Mortality and Morbidity After Hip Fracture Using Monocyte Distribution Width (MDW)
An observational study of Sepsis and Osteoporotic Hip Fracture, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
Hip fracture is a common injury in older adults and is often associated with serious complications, longer hospital stays, and increased risk of death. One of the most important causes of poor outcomes after hip fracture surgery is infection, including severe infections such as sepsis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sepsis, Osteoporotic Hip Fracture, Hip Fracture
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population includes approximately 100 geriatric patients aged 65 years and older admitted with low-energy hip fractures and treated surgically at the 2nd Orthopaedic Department of the General Hospital of Attica KAT. Participants undergo routine perioperative evaluation, including demographic and clinical data collection and laboratory assessment of inflammatory biomarkers such as monocyte distribution width (MDW), C-reactive protein, procalcitonin, and antithrombin III. Patients are followed prospectively to evaluate postoperative morbidity and all-cause mortality at 1 month, 3 months, and 12 months following surgery.
Who may be able to join
- Patients aged ≥65 years
- Admission with low-energy hip fracture (femoral neck, intertrochanteric, or subtrochanteric fracture)
- Admission to General Hospital of Attica KAT
- Availability of baseline laboratory measurements, including complete blood count with monocyte distribution width (MDW) and inflammatory biomarkers
Who cannot join
- Age <65 years
- High-energy trauma-related hip fractures
- Pathological fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Laboratory for Research of the Musculoskeletal System
Kifissia, Attica, 14561
Efstathios Chronopoulos, Prof., 00306944837793, stathi24@yahoo.gr
Lamprini Agapitou, 00306943550207, labrini.agapitou@gmail.com
About this study
Official title: The Role of Monocyte Distribution Width (MDW) and Other Inflammatory Biomarkers in the Prediction of Mortality and Morbidity in Patients With Hip Fracture
Hip fracture is a common injury in older adults and is often associated with serious complications, longer hospital stays, and increased risk of death. One of the most important causes of poor outcomes after hip fracture surgery is infection, including severe infections such as sepsis. Early identification of patients at higher risk for complications could help improve treatment and survival.
This study aims to examine whether a blood test parameter called Monocyte Distribution Width (MDW), along with other commonly used inflammatory markers, can help predict complications and survival in elderly patients with hip fracture. MDW is measured as part of a routine complete blood count and has shown promise in the early detection of infection and systemic inflammation.
Read more
Approximately 100 patients aged 65 years or older who are admitted to the hospital with a low-energy hip fracture will be included in this study. Blood tests will be performed at hospital admission, after surgery, and at other time points as part of standard clinical care. These tests include routine blood counts and inflammatory markers such as C-reactive protein (CRP), procalcitonin (PCT), antithrombin III, and MDW. No additional invasive procedures are required beyond standard medical care.
Researchers will collect information about each patient's medical history, overall health status, and daily activity level before the fracture. Patients will be followed after surgery to assess complications, length of hospital stay, and survival at 1 month, 3 months, and 1 year.
The results of this study may help determine whether MDW can be used as a simple and reliable marker to identify patients at higher risk of complications or death after hip fracture. This could support earlier intervention, closer monitoring, and improved care for elderly patients with hip fractures in the future.
- Conditions
- Sepsis, Osteoporotic Hip Fracture, Hip Fracture
- Keywords
- Monocyte Distribution Width (MDW), Geriatric Patients, Inflammatory Biomarkers, Postoperative Mortality, Postoperative Morbidity, C-reactive Protein, Procalcitonin, Antithrombin III, Hip Fracture
- Medical subject headings
- Sepsis, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Patients With Hip Fracture | This cohort consists of patients aged 65 years or older who are admitted with a low-energy hip fracture and undergo surgical treatment. All participants receive standard-of-care clinical management according to institutional protocols. No experimental interventions are assigned as part of this study. Clinical data, medical history, and pre-fracture functional status are recorded at baseline. Blood samples are collected as part of routine care at hospital admission, postoperatively, and at discharge to measure complete blood count parameters, including Monocyte Distribution Width (MDW), and other inflammatory markers such as C-reactive protein, procalcitonin, and antithrombin III. Participants are followed postoperatively to assess clinical outcomes, including complications, morbidity, mortality, and health-related quality of life. Comparisons will be performed between subgroups defined by clinical outcomes or biomarker levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Assessment of all-cause mortality in geriatric patients with low-energy hip fracture and its association with Monocyte Distribution Width (MDW) values measured at admission and during hospitalization.
Measured: Up to 12 months postoperatively.
Secondary outcomes (4)
Postoperative morbidity
Assessment of postoperative morbidity, including infectious and non-infectious complications, and its association with Monocyte Distribution Width (MDW) and other inflammatory markers (C-reactive protein, procalcitonin, antithrombin III).
Measured: From postoperative day 1 through study completion, an average of 1 year.
Incidence of sepsis
Occurrence of sepsis during hospitalization or postoperative follow-up, evaluated in relation to MDW values and other inflammatory biomarkers.
Measured: From postoperative day 1 through study completion, an average of 1 year.
Change in Monocyte Distribution Width (MDW) over time
Evaluation of changes in MDW values from admission through the postoperative period and at discharge, and their association with clinical outcomes.
Measured: From hospital admission through hospital discharge, up to 14 days postoperatively.
Length of hospital stay
Duration of hospitalization measured in days and its association with MDW and inflammatory marker levels.
Measured: From the date of hospital admission until hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
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.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EFSTATHIOS CHRONOPOULOS, National and Kapodistrian University of Athens
- Investigators
- Efstathios Chronopoulos, Study director, KAT General Hospital, Athens Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350785
- Sponsor's protocol ID
- 5570/04-03-2025
- Acronym
- MDW
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Data sharing will comply with the General Data Protection Regulation (EU GDPR) and applicable ethical and institutional requirements. Requests must include a brief description of the intended research use. Approved requests will be granted access to fully anonymized data sets, ensuring that study participants cannot be identified.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Monocyte Distribution Width (MDW) and Other Inflammatory Biomarkers in the Prediction of Mortality and Morbidity in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT07350785
- Acronym / sponsor ID
- MDW / 5570/04-03-2025
- Conditions
- Sepsis, Osteoporotic Hip Fracture, Hip Fracture
- Keywords
- Monocyte Distribution Width (MDW), Geriatric Patients, Inflammatory Biomarkers, Postoperative Mortality, Postoperative Morbidity, C-reactive Protein, Procalcitonin, Antithrombin III
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
Hip fracture is a common injury in older adults and is often associated with serious complications, longer hospital stays, and increased risk of death. One of the most important causes of poor outcomes after hip fracture surgery is infection, including severe infections such as sepsis. Early identification of patients at higher risk for complications could help improve treatment and survival.
This study aims to examine whether a blood test parameter called Monocyte Distribution Width (MDW), along with other commonly used inflammatory markers, can help predict complications and survival in elderly patients with hip fracture. MDW is measured as part of a routine complete blood count and has shown promise in the early detection of infection and systemic inflammation.
Approximately 100 patients aged 65 years or older who are admitted to the hospital with a low-energy hip fracture will be included in this study. Blood tests will be performed at hospital admission, after surgery, and at other time points as part of standard clinical care. These tests include routine blood counts and inflammatory markers such as C-reactive protein (CRP), procalcitonin (PCT), antithrombin III, and MDW. No additional invasive procedures are required beyond standard medical care.
Researchers will collect information about each patient's medical history, overall health status, and daily activity level before the fracture. Patients will be followed after surgery to assess complications, length of hospital stay, and survival at 1 month, 3 months, and 1 year.
The results of this study may help determine whether MDW can be used as a simple and reliable marker to identify patients at higher risk of complications or death after hip fracture. This could support earlier intervention, closer monitoring, and improved care for elderly patients with hip fractures in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Patients With Hip Fracture | – | –This cohort consists of patients aged 65 years or older who are admitted with a low-energy hip fracture and undergo surgical treatment. All participants receive standard-of-care clinical management according to institutional protocols. No experimental interventions are assigned as part of this study. Clinical data, medical history, and pre-fracture functional status are recorded at baseline. Blood samples are collected as part of routine care at hospital admission, postoperatively, and at discharge to measure complete blood count parameters, including Monocyte Distribution Width (MDW), and other inflammatory markers such as C-reactive protein, procalcitonin, and antithrombin III. Participants are followed postoperatively to assess clinical outcomes, including complications, morbidity, mortality, and health-related quality of life. Comparisons will be performed between subgroups defined by clinical outcomes or biomarker levels. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population includes approximately 100 geriatric patients aged 65 years and older admitted with low-energy hip fractures and treated surgically at the 2nd Orthopaedic Department of the General Hospital of Attica KAT. Participants undergo routine perioperative evaluation, including demographic and clinical data collection and laboratory assessment of inflammatory biomarkers such as monocyte distribution width (MDW), C-reactive protein, procalcitonin, and antithrombin III. Patients are followed prospectively to evaluate postoperative morbidity and all-cause mortality at 1 month, 3 months, and 12 months following surgery.
Key inclusion criteria (4 listed)
- Patients aged ≥65 years
- Admission with low-energy hip fracture (femoral neck, intertrochanteric, or subtrochanteric fracture)
- Admission to General Hospital of Attica KAT
- Availability of baseline laboratory measurements, including complete blood count with monocyte distribution width (MDW) and inflammatory biomarkers
Key exclusion criteria (3 listed)
- Age <65 years
- High-energy trauma-related hip fractures
- Pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: Up to 12 months postoperatively.
Assessment of all-cause mortality in geriatric patients with low-energy hip fracture and its association with Monocyte Distribution Width (MDW) values measured at admission and during hospitalization.
4 secondary outcomes
Postoperative morbidity
Time frame: From postoperative day 1 through study completion, an average of 1 year.
Incidence of sepsis
Time frame: From postoperative day 1 through study completion, an average of 1 year.
Change in Monocyte Distribution Width (MDW) over time
Time frame: From hospital admission through hospital discharge, up to 14 days postoperatively.
Length of hospital stay
Time frame: From the date of hospital admission until hospital discharge, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Data sharing will comply with the General Data Protection Regulation (EU GDPR) and applicable ethical and institutional requirements. Requests must include a brief description of the intended research use. Approved requests will be granted access to fully anonymized data sets, ensuring that study participants cannot be identified.
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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.
Efstathios Chronopoulos study director
KAT General Hospital, Athens Greece
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 and Osteoporotic Hip Fracture, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efstathios Chronopoulos (00306944837793, stathi24@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Up to 12 months postoperatively.). 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 20 Jan 2026.