Investigation of the Relationship Between MD, MLR and NLR With APRs in Sepsis in the ICU

April 12, 2026 updated by: Oguz Gundogdu

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

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

  • Turkey (Türkiye)
    • Sivas
      • Sivas, Sivas, Turkey (Türkiye), 58140
        • Sivas Cumhuriyet University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients monitored in the intensive care unit for at least 24 hours
  • Age over 18 years
  • Diagnosis of sepsis or septic shock

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Monocyte Distribution
The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range.
Group-II
Group II: patients who were admitted to the intensive care unit for reasons other than sepsis and subsequently developed sepsis
Diagnostic test: Monocyte Distribution
The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range.
Group-III
Group III: patients admitted to the intensive care unit with a primary diagnosis of sepsis.
Diagnostic test: Monocyte Distribution
The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)]
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SOFA and APACHE-II scores
Time Frame: Within the first 24 hours following the diagnosis of sepsis
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)
Within the first 24 hours following the diagnosis of sepsis

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oguz Gundogdu

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-09/06

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

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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