Inflammatory Markers and Clinical Score in Predicting Mortality

March 12, 2026 updated by: basma sayed ahmed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Estimated)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Septic patient on icu

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Septic patient
Adult patient above 18 years admitted to icu with confirmed diagnosis of sepsis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of inflamatory markers in survival patient compare to dead patient
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Khaled Mohamed Ali

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clinical Scores in sepsis pati

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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