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临床试验/NCT07493759
NCT07493759已完成不适用

The Relationship Between Systematic Inflammatory Index (SII) and Mortality in Patients Admitted to the Non-Interventional Clinical Research Ethics Committee for Evalation

Ataturk University1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
570
试验地点
1
主要终点
ICU Mortality Rate

研究概览

简要总结

Systemic Immune-Inflammation Index (SII) is a hemogram-derived biomarker reflecting the balance between systemic inflammation and immune response. In critically ill patients, inflammatory burden at admission may play a key role in prognosis. This retrospective cohort study aims to evaluate the association between admission SII levels and intensive care unit (ICU) mortality in adult patients admitted to a reanimation ICU. Secondary objectives include comparison of mortality according to infectious versus non-infectious admission diagnoses and assessment of the relationship between SII and established severity scores, including APACHE II and Glasgow Coma Scale (GCS). The findings may support the use of SII as a rapid, inexpensive prognostic marker in critically ill patients.

详细描述

Systemic inflammation is a fundamental component of critical illness and has a strong association with disease severity and mortality in intensive care units. The Systemic Immune-Inflammation Index (SII), calculated from neutrophil, lymphocyte, and platelet counts, has emerged as a quantitative marker of systemic immune-inflammatory status. While SII has been studied in various clinical settings, its prognostic value in reanimation ICU patients remains insufficiently defined.

This study is designed as a single-center, retrospective, non-interventional cohort study conducted in the Reanimation Intensive Care Unit of Atatürk University Research Hospital. Adult patients (≥18 years) admitted to the ICU for infectious or non-infectious critical illnesses will be evaluated through retrospective review of hospital electronic medical records (ENLİL Hospital Information Management System).

Patients will be included if admission laboratory data, including complete blood count and biochemical parameters, are available. Exclusion criteria include pregnancy, hematologic malignancy, active chemotherapy, chronic immunosuppression, pulse steroid therapy, known severe thrombocytopenia (<50×10⁹/L), massive bleeding or massive transfusion within the first 24 hours, and incomplete clinical or laboratory data.

The primary outcome of the study is the association between admission SII levels and ICU mortality. Secondary outcomes include comparison of mortality rates between infectious and non-infectious admission diagnoses, evaluation of correlations between SII and APACHE II and GCS scores, and assessment of whether elevated SII is an independent risk factor for ICU mortality.

Sample size calculation was performed using G*Power software based on a reference population study, assuming a mean SII value of 515±170 in the control group. To detect a 40-unit difference in SII between infectious and non-infectious groups with 80% power and a 95% confidence level, a minimum of 285 patients per group (total ≥570 patients) is required.

研究设计

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

入排标准

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

入选标准

  • Age 18 years or older
  • Admission to the reanimation intensive care unit
  • Availability of admission complete blood count and biochemical laboratory data
  • Admission due to infectious or non-infectious critical illness

排除标准

  • Pregnancy
  • Hematologic malignancy
  • Active chemotherapy
  • Chronic immunosuppression
  • Pulse steroid therapy
  • Known thrombocytopenia (platelet count <50×10^9/L)
  • Massive bleeding or massive transfusion within the first 24 hours of ICU admission
  • Incomplete clinical or laboratory data

结局指标

主要结局

ICU Mortality Rate

时间窗: Duration of ICU stay (up to 90 days)

All-cause mortality during ICU stay, compared between patients with high vs. low SII values

次要结局

  • Systemic Immune-Inflammation Index (SII)(At ICU admission (Day 0))
  • APACHE II Score(First 24 hours of ICU admission)
  • Glasgow Coma Scale (GCS) Score(At ICU admission (Day 0))

研究者

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

Nazim Dogan Prof. M.D

Prof. Dr.

Ataturk University

研究点 (1)

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