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

NCT07537179 | Completed

• 1 other identifier: 2022-09/06
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 conventional biomarkers, and to examine their relationships with these biomarkers.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SOFA and APACHE-II scores

  Within the first 24 hours following the diagnosis of sepsis

Study Arms (3)

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

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

Group-III

Group III: patients admitted to the intensive care unit with a primary diagnosis of sepsis.

Diagnostic Test: Monocyte Distribution

Interventions

Monocyte Distribution DIAGNOSTIC_TEST

The monocyte distribution parameter is a research parameter within the complete blood count and does not have a defined reference laboratory range.

Group-I: Control; Group-II; Group-III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oguz Gundogdu: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 17, 2026
• Study Start: October 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)