NCT07464054

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2026

Last Update Submit

March 12, 2026

Conditions

Inflamatory Markers

Outcome Measures

Primary Outcomes (1)

  • Level of inflamatory markers in survival patient compare to dead patient

    Baseline

Study Arms (1)

Septic patient

Adult patient above 18 years admitted to icu with confirmed diagnosis of sepsis

Diagnostic Test: Blood samples for aboratory test

Interventions

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

Septic patient

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Septic patient on icu

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Zhang Y,Peng W,Zheng X

    RESULT

  • Czempik PF,Wiórek A

    RESULT

  • Nayak SS,Behera BK,Thatoi PK,Mohanty NR

    RESULT

  • Tuttle E,Wang X,Modrykamien A

    RESULT

  • Koçak A,Urfalı S

    RESULT

  • Azmakan H,Hashemian F,Kazemian K

    RESULT

  • Yao W,Wang W,Tang W,Lv Q,Ding W

    RESULT

  • Selewski DT,Wille KM

    RESULT

  • Abd-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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 37657884RESULT

  • La 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.

    PMID: 39189251RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Khaled Mohamed Ali

    STUDY DIRECTOR

Central Study Contacts

Basma Sayed Ahmed

CONTACT

+201141379697drbasmasayed@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident hematology at qena university hospital

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 11, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share