Inflamatory MarkersNCT07464054
Inflammatory Markers and Clinical Score in Predicting Mortality
An observational study of Inflamatory Markers, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inflamatory Markers
- What is being tested?
- Blood samples for aboratory test
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic patient on icu
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Inflamatory Markers
- Being tested
- Blood samples for aboratory test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for aboratory testDiagnostic test
Laboratory test using blood samples to get some parameters as cbc to predict mortality in septic patient in compare with clinical scores
| Study group | Role | What they receive |
|---|---|---|
| Septic patient | Adult patient above 18 years admitted to icu with confirmed diagnosis of sepsis Receives: Diagnostic Test: Blood samples for aboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of inflamatory markers in survival patient compare to dead patient
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Inflamatory MarkersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, basma sayed ahmed, Assiut University
- Investigators
- Khaled Mohamed Ali, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464054
- Sponsor's protocol ID
- Clinical Scores in sepsis pati
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38956445Czempik 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.
PubMed 40364273Nayak 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.
PubMed 40256093Tuttle 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.
PubMed 37074499Kocak 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.
PubMed 40870363Azmakan 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.
PubMed 40051492Yao 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.
PubMed 37697317Selewski 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.
PubMed 33765346Abd-Elfattah AH, Khaled MM, Ahmed AA, Yahia M, Kotrob AM. Comparison of Presepsin (CD14), Procalcitonin (PCT) and C-reactive protein (CRP) at different SOFA and APACHE II scores in sepsis patients. International Journal of Health Sciences. 2022(III):3840-64.
Cebeci Y, Bayraktar YŞ. Association between Platelet-to-Lymphocyte Ratio, C-reactive Protein to Albumin Ratio, Red Cell Distribution Width, and APACHE II Score in Predicting Prognosis and Mortality in Sepsis. Eurasian Journal of Emergency Medicine. 2025 Jun 4.
Reddy V, Kumar S. Comparison of Neutrophil Lymphocyte Ratio combined SOFA versus APACHE IV in assessing the Prognosis of Sepsis Patients admitted to Medical Intensive Care Unit. F1000Research. 2024 Apr 26;13:403.
Abass AM, Abdelzaher TA. Clinical Scores Can Predict Mortality in Septic Patients in the Intensive Care Unit. Minia Journal of Medical Research. 2024 Apr 1;35(2):220-30.
Bohorquez H, Koyner JL, Jones CR. Intraoperative Renal Replacement Therapy in Orthotopic Liver Transplantation. Adv Kidney Dis Health. 2023 Jul;30(4):378-386. doi: 10.1053/j.akdh.2023.03.003.
PubMed 37657884La Via L, Sangiorgio G, Stefani S, Marino A, Nunnari G, Cocuzza S, La Mantia I, Cacopardo B, Stracquadanio S, Spampinato S, Lavalle S, Maniaci A. The Global Burden of Sepsis and Septic Shock. Epidemiologia (Basel). 2024 Jul 25;5(3):456-478. doi: 10.3390/epidemiologia5030032.
PubMed 39189251
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Nutritional Biomarkers Versus Clinical Scores in Predicting Mortality and Severity in Sepsis Patients
- ClinicalTrials.gov ID
- NCT07464054
- Acronym / sponsor ID
- Clinical Scores in sepsis pati
- Conditions
- Inflamatory Markers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic patient | – | Diagnostic Test: Blood samples for aboratory testAdult patient above 18 years admitted to icu with confirmed diagnosis of sepsis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic patient on icu
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for aboratory testLaboratory test using blood samples to get some parameters as cbc to predict mortality in septic patient in compare with clinical scores | Diagnostic test | Septic patient |
Primary outcome
Level of inflamatory markers in survival patient compare to dead patient
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 38956445Zhang 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.
- Results publication: PubMed 40364273Czempik 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.
- Results publication: PubMed 40256093Nayak 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.
- Results publication: PubMed 37074499Tuttle 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.
- Results publication: PubMed 40870363Kocak 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.
- Results publication: PubMed 40051492Azmakan 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.
- Results publication: PubMed 37697317Yao 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.
- Results publication: PubMed 33765346Selewski 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.
- Results publicationAbd-Elfattah AH, Khaled MM, Ahmed AA, Yahia M, Kotrob AM. Comparison of Presepsin (CD14), Procalcitonin (PCT) and C-reactive protein (CRP) at different SOFA and APACHE II scores in sepsis patients. International Journal of Health Sciences. 2022(III):3840-64.
- Results publicationCebeci Y, Bayraktar YŞ. Association between Platelet-to-Lymphocyte Ratio, C-reactive Protein to Albumin Ratio, Red Cell Distribution Width, and APACHE II Score in Predicting Prognosis and Mortality in Sepsis. Eurasian Journal of Emergency Medicine. 2025 Jun 4.
- Results publicationReddy V, Kumar S. Comparison of Neutrophil Lymphocyte Ratio combined SOFA versus APACHE IV in assessing the Prognosis of Sepsis Patients admitted to Medical Intensive Care Unit. F1000Research. 2024 Apr 26;13:403.
- Results publicationAbass AM, Abdelzaher TA. Clinical Scores Can Predict Mortality in Septic Patients in the Intensive Care Unit. Minia Journal of Medical Research. 2024 Apr 1;35(2):220-30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaled Mohamed Ali study director
Questions about this trial
What is this clinical trial studying?
An observational study of Inflamatory Markers, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basma Sayed Ahmed (+201141379697, drbasmasayed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of inflamatory markers in survival patient compare to dead patient (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464054, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.