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NCT Number: NCT07464054

Inflammatory Markers and Clinical Score in Predicting Mortality

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.

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Blood samples for aboratory test

Diagnostic Test

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

Primary outcomes

  1. Level of inflamatory markers in survival patient compare to dead patient

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Basma Sayed Ahmed

CONTACT

[email protected]

+201141379697

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 16, 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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