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临床试验/NCT07464054
NCT07464054尚未招募不适用

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

Assiut University0 个研究点目标入组 61 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
61
主要终点
Level of inflamatory markers in survival patient compare to dead patient

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Septic patient

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

干预措施: Blood samples for aboratory test (Diagnostic Test)

结局指标

主要结局

Level of inflamatory markers in survival patient compare to dead patient

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

basma sayed ahmed

Resident hematology at qena university hospital

Assiut University

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