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

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: Completed
• Conditions: Sepsis; Intensive Care (ICU); Acute Phase Biomarkers
• Intervention / Treatment: Diagnostic test: Monocyte Distribution

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: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)]	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within the first 24 hours following the diagnosis of sepsis

Collaborators and Investigators

• Sponsor: Oguz Gundogdu

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Sepsis; Neutrophil-to-Lymphocyte Ratio; Monocyte-to-Lymphocyte Ratio; Monocyte Distribution; Acute Phase Reactans
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID 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