SepsisNCT07537179
Investigation of the Relationship Between MD, MLR and NLR With APRs in Sepsis in the ICU
An observational study of Sepsis and Intensive Care (ICU), run by Oguz Gundogdu at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate, in patients admitted to the intensive care unit either for reasons other than sepsis who subsequently develop sepsis or with a primary diagnosis of sepsis, whether monocyte distribution, monocyte-to-lymphocyte ratio, and neutrophil-to-lymphocyte ratio can be used in addition to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Intensive Care (ICU), Acute Phase Biomarkers
- What is being tested?
- Monocyte Distribution
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Jan 2024
- How long will I take part?
- 15 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of three groups: Group I: Control group - patients over 18 years of age, classified as ASA I-II, with no infection, who applied to the anesthesia outpatient clinic and did not meet any exclusion criteria; Group II: patients who were admitted to the intensive care unit for reasons other than sepsis and subsequently developed sepsis; Group III: patients admitted to the intensive care unit with a primary diagnosis of sepsis.
Who may be able to join
- Patients monitored in the intensive care unit for at least 24 hours
- Age over 18 years
- Diagnosis of sepsis or septic shock
Who cannot join
- Patients with hematological diseases
- Patients who have undergone organ or bone marrow transplantation
- Patients diagnosed with AIDS
- Patients receiving immunosuppressive therapy for any reason
- Patients with chronic renal failure
- Patients with liver failure not related to sepsis
- Patients admitted due to intoxication
- Patients with intracranial pathologies (e.g., mass, hemorrhage) that may lead to morbidity due to volume loading
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas, 58140
About this study
Official title: Investigation of the Relationship Between Monocyte Distribution, Monocyte-to-Lymphocyte Ratio and Neutrophil-to-Lymphocyte Ratio With Acute Phase Reactants in Sepsis in the Intensive Care Unit
The aim of this study is to investigate, in patients admitted to the intensive care unit either for reasons other than sepsis who subsequently develop sepsis or with a primary diagnosis of sepsis, whether monocyte distribution, monocyte-to-lymphocyte ratio, and neutrophil-to-lymphocyte ratio can be used in addition to conventional biomarkers, and to examine their relationships with these biomarkers.
Read the detailed description
For Group I (control group) patients, WBC, NLR, MLR, and monocyte distribution(MD) parameters obtained from the complete blood count on the day of their anesthesia outpatient clinic visit were used in the study. For Group II and Group III patients, on the day of sepsis diagnosis, lactate, CRP, PCT, WBC, NLR, MLR, and monocyte distribution(MD) values were recorded. For Groups II and III, SOFA and APACHE-II scores were calculated within the first 24 hours and documented. The day of sepsis diagnosis was defined as T0, and subsequent measurements of lactate, CRP, PCT, WBC, NLR, MLR, and monocyte distribution(MD) were recorded every 48 hours until sepsis resolution, discharge, or death, as T1, T2, T3, and T4, respectively. The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range. In our study, statistical analysis of monocyte distribution(MD), MLR and NLR values from the control group was performed to determine a cut-off value.
- Conditions
- Sepsis, Intensive Care (ICU), Acute Phase Biomarkers
- Being tested
- Monocyte Distribution
- Keywords
- Monocyte Distribution, Monocyte-to-Lymphocyte Ratio, Neutrophil-to-Lymphocyte Ratio, Acute Phase Reactans, Sepsis, Intensive Care Unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocyte DistributionDiagnostic test
The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range.
| Study group | Role | What they receive |
|---|---|---|
| Group-I: Control | Control group - patients over 18 years of age, classified as ASA I-II, with no infection, who applied to the anesthesia outpatient clinic and did not meet any exclusion criteria. Receives: Diagnostic Test: Monocyte Distribution | |
| Group-II | Group II: patients who were admitted to the intensive care unit for reasons other than sepsis and subsequently developed sepsis Receives: Diagnostic Test: Monocyte Distribution | |
| Group-III | Group III: patients admitted to the intensive care unit with a primary diagnosis of sepsis. Receives: Diagnostic Test: Monocyte Distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
WBC,NLR,MLR,MD,LACTATE,CRP,PCT
For Group I (control group) patients WBC, NLR, MLR and monocyte distribution(MD) parameters obtained from the complete blood count on the day of their anesthesia outpatient clinic visit were used in the study. For Group II and Group III patients, on the day of sepsis diagnosis, lactate, CRP, PCT, WBC, NLR, MLR and monocyte distribution(MD) values were recorded. The day of sepsis diagnosis was defined as T0 and subsequent measurements of lactate, CRP, PCT, WBC, NLR, MLR, and MD were recorded every 48 hours until sepsis resolution, dischargevor death as T1, T2, T3, and T4, respectively. The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range. In our study, statistical analysis of MD, MLR and NLR values from the control group was performed to determine a cut-off value. [WBC 10^3/mm3, CRP mg/L, PCT ng/mL,Lactate mmol/L, NLR 2-90(min-max), MLR 0.24-1.3(min-max), MD 8.9-13(min-max)]
Measured: 15 days
Secondary outcomes (1)
SOFA and APACHE-II scores
For Groups II and III, SOFA and APACHE-II scores were calculated within the first 24 hours and documented. (SOFA score >2, APACHE-II score between 0-71)
Measured: Within the first 24 hours following the diagnosis of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Oct 2022
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Oguz Gundogdu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oguz Gundogdu, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537179
- Sponsor's protocol ID
- 2022-09/06
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Monocyte Distribution, Monocyte-to-Lymphocyte Ratio and Neutrophil-to-Lymphocyte Ratio With Acute Phase Reactants in Sepsis in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07537179
- Acronym / sponsor ID
- 2022-09/06
- Conditions
- Sepsis, Intensive Care (ICU), Acute Phase Biomarkers
- Keywords
- Monocyte Distribution, Monocyte-to-Lymphocyte Ratio, Neutrophil-to-Lymphocyte Ratio, Acute Phase Reactans, Sepsis, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oguz GundogduUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 17 Apr 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.
The aim of this study is to investigate, in patients admitted to the intensive care unit either for reasons other than sepsis who subsequently develop sepsis or with a primary diagnosis of sepsis, whether monocyte distribution, monocyte-to-lymphocyte ratio, and neutrophil-to-lymphocyte ratio can be used in addition to conventional biomarkers, and to examine their relationships with these biomarkers.
Detailed description
For Group I (control group) patients, WBC, NLR, MLR, and monocyte distribution(MD) parameters obtained from the complete blood count on the day of their anesthesia outpatient clinic visit were used in the study. For Group II and Group III patients, on the day of sepsis diagnosis, lactate, CRP, PCT, WBC, NLR, MLR, and monocyte distribution(MD) values were recorded. For Groups II and III, SOFA and APACHE-II scores were calculated within the first 24 hours and documented. The day of sepsis diagnosis was defined as T0, and subsequent measurements of lactate, CRP, PCT, WBC, NLR, MLR, and monocyte distribution(MD) were recorded every 48 hours until sepsis resolution, discharge, or death, as T1, T2, T3, and T4, respectively. The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range. In our study, statistical analysis of monocyte distribution(MD), MLR and NLR values from the control group was performed to determine a cut-off value.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-I: Control | – | Diagnostic Test: Monocyte DistributionControl group - patients over 18 years of age, classified as ASA I-II, with no infection, who applied to the anesthesia outpatient clinic and did not meet any exclusion criteria. |
| Group-II | – | Diagnostic Test: Monocyte DistributionGroup II: patients who were admitted to the intensive care unit for reasons other than sepsis and subsequently developed sepsis |
| Group-III | – | Diagnostic Test: Monocyte DistributionGroup III: patients admitted to the intensive care unit with a primary diagnosis of sepsis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of three groups: Group I: Control group - patients over 18 years of age, classified as ASA I-II, with no infection, who applied to the anesthesia outpatient clinic and did not meet any exclusion criteria; Group II: patients who were admitted to the intensive care unit for reasons other than sepsis and subsequently developed sepsis; Group III: patients admitted to the intensive care unit with a primary diagnosis of sepsis.
Key inclusion criteria (3 listed)
- Patients monitored in the intensive care unit for at least 24 hours
- Age over 18 years
- Diagnosis of sepsis or septic shock
Key exclusion criteria (8 listed)
- Patients with hematological diseases
- Patients who have undergone organ or bone marrow transplantation
- Patients diagnosed with AIDS
- Patients receiving immunosuppressive therapy for any reason
- Patients with chronic renal failure
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 DistributionThe monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range. | Diagnostic test | Group-I: Control, Group-II, Group-III |
Primary outcome
WBC,NLR,MLR,MD,LACTATE,CRP,PCT
Time frame: 15 days
For Group I (control group) patients WBC, NLR, MLR and monocyte distribution(MD) parameters obtained from the complete blood count on the day of their anesthesia outpatient clinic visit were used in the study. For Group II and Group III patients, on the day of sepsis diagnosis, lactate, CRP, PCT, WBC, NLR, MLR and monocyte distribution(MD) values were recorded. The day of sepsis diagnosis was defined as T0 and subsequent measurements of lactate, CRP, PCT, WBC, NLR, MLR, and MD were recorded every 48 hours until sepsis resolution, dischargevor death as T1, T2, T3, and T4, respectively. The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range. In our study, statistical analysis of MD, MLR and NLR values from the control group was performed to determine a cut-off value. [WBC 10^3/mm3, CRP mg/L, PCT ng/mL,Lactate mmol/L, NLR 2-90(min-max), MLR 0.24-1.3(min-max), MD 8.9-13(min-max)]
1 secondary outcome
SOFA and APACHE-II scores
Time frame: Within the first 24 hours following the diagnosis of sepsis
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 17 Apr 2026.
- 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 and Intensive Care (ICU), run by Oguz Gundogdu at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 17 Apr 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 Turkey (Türkiye). 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?
WBC,NLR,MLR,MD,LACTATE,CRP,PCT (time frame: 15 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 17 Apr 2026.