Inflammatory Markers and Clinical Score in Predicting Mortality

Official title

Inflammatory and Nutritional Biomarkers Versus Clinical Scores in Predicting Mortality and Severity in Sepsis Patients

Overview

To evaluate the prognostic value of inflammatory markers; specifically neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic inflammation immune index (SII) in predicting the severity and outcomes of patients with sepsis, and to compare their predictive accuracy with established clinical scoring systems such as the SOFA (Sequential Organ Failure Assessment) score and APACHE (Acute Physiology and Chronic Health Evaluation) score.

Detailed description

Sepsis is a life-threatening condition and a major global health burden, representing one of the leading causes of ICU admission worldwide . Despite advances in diagnosis and treatment, it remains associated with high mortality, particularly among critically ill and elderly patients, with an estimated 48 million cases and 11 million deaths globally in 2017 . Its defined as organ dysfunction caused by a dysregulated host response to infection; sepsis is a medical emergency requiring prompt recognition and early management . Survivors often experience long-term physical, cognitive, and psychological impairments, highlighting the need for early risk stratification and identification of patients at high risk to guide clinical decision-making and optimize ICU resource allocation .

Several clinical scoring systems have been developed to assess disease severity and predict mortality in septic patients. Among these, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score is one of the most extensively validated tools and has demonstrated good discriminatory ability for predicting shortterm mortality in sepsis .

Similarly, the Sepsisrelated Organ Failure Assessment (SOFA) score is widely used for both the diagnosis and prognostic evaluation of sepsis in ICU settings. Its simplified version, the quick SOFA (qSOFA), is primarily utilized outside the ICU to identify patients at increased risk of poor outcomes and the need for prolonged ICU admission. However, while these scoring systems are useful, their predictive performance is not optimal when used in isolation, highlighting the need for complementary biomarkers .

In addition to clinical scores, hematological and immuno-inflammatory indices derived from the complete blood count (CBC) have emerged as valuable prognostic biomarkers . Red cell distribution width (RDW) has been independently associated with sepsis severity and mortality, with higher values observed in non-survivors .

Inflammatory ratios such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII) reflect systemic immune activation and have shown significant associations with adverse outcomes .

Emerging indices such as the prognostic nutritional index (PNI) and the neutrophil-to-platelet ratio (NPR) provide additional insight into the patients immune and nutritional status, further enhancing mortality prediction when combined with conventional scoring systems .

Integrating established clinical severity scores, inflammatory markers such as Creactive protein (CRP), and hematological parameters from the CBC may enhance the accuracy of mortality prediction in septic ICU patients. Such an approach aligns with the growing interest in combining clinical and laboratorybased predictors to improve early risk stratification and guide targeted therapeutic interventions in sepsis .

Interventions

• Diagnostic test Blood samples for aboratory test
  Laboratory test using blood samples to get some parameters as cbc to predict mortality in septic patient in compare with clinical scores

Primary outcome measures

• Level of inflamatory markers in survival patient compare to dead patient [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Adults aged ≥18 years.
• Admission to ICU with a confirmed diagnosis of sepsis based on current Sepsis-3 criteria.
• Availability of complete baseline laboratory data.

Exclusion criteria

• Patients with hematological malignancies or active chemotherapy. Patients with chronic immunosuppressive therapy (e.g., post-transplant, high-dose corticosteroids).
• Pregnant or lactating women.
• ICU stay less than 24 hours.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Zhang Y, Peng W, Zheng X. The prognostic value of the combined neutrophil-to-lymphocyte ratio (NLR) and neutrophil-to-platelet ratio (NPR) in sepsis. Sci Rep. 2024 Jul 2;14(1):15075. doi: 10.1038/s41598-024-64469-8. PMID 38956445
• Czempik PF, Wiorek A. Extended Hematological Parameters and Short-Term Mortality in Sepsis Patients: A Retrospective Study. J Clin Med. 2025 May 7;14(9):3243. doi: 10.3390/jcm14093243. PMID 40364273
• Nayak SS, Behera BK, Thatoi PK, Mohanty NR. Neutrophil-to-lymphocyte ratio in predicting mortality in sepsis and its correlation with sofa score and C-reactive protein values. J Family Med Prim Care. 2025 Mar;14(3):839-849. doi: 10.4103/jfmpc.jfmpc_963_24. Epub 2025 Mar 25. PMID 40256093
• Tuttle E, Wang X, Modrykamien A. Sepsis mortality and ICU length of stay after the implementation of an intensive care team in the emergency department. Intern Emerg Med. 2023 Sep;18(6):1789-1796. doi: 10.1007/s11739-023-03265-0. Epub 2023 Apr 19. PMID 37074499
• Kocak A, Urfali S. A Retrospective Analysis of the Predictive Role of RDW, MPV, and MPV/PLT Values in 28-Day Mortality of Geriatric Sepsis Patients: Associations with APACHE II and SAPS II Scores. Medicina (Kaunas). 2025 Jul 22;61(8):1318. doi: 10.3390/medicina61081318. PMID 40870363
• Azmakan H, Hashemian F, Kazemian K. Evaluation of Novel Combined CBC-Derived Systemic Inflammatory Ratios and Their Dynamic Changes as ICU Mortality Predictors, a Retrospective Cohort. Health Sci Rep. 2025 Mar 5;8(3):e70441. doi: 10.1002/hsr2.70441. eCollection 2025 Mar. PMID 40051492
• Yao W, Wang W, Tang W, Lv Q, Ding W. Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune inflammation index (SII) to predict postoperative pneumonia in elderly hip fracture patients. J Orthop Surg Res. 2023 Sep 12;18(1):673. doi: 10.1186/s13018-023-04157-x. PMID 37697317
• Selewski DT, Wille KM. Continuous renal replacement therapy in patients treated with extracorporeal membrane oxygenation. Semin Dial. 2021 Nov;34(6):537-549. doi: 10.1111/sdi.12965. Epub 2021 Mar 25. PMID 33765346

Identifiers

NCT: NCT07464054 · Clinical Scores in sepsis pati

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗