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Completed

NCT Number: NCT07537179

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

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.

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Key information

Conditions

Sepsis Acute Phase Biomarkers Infections Inflammation Intensive Care (ICU) Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)]

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Oguz Gundogdu

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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