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临床试验/NCT07332637
NCT07332637尚未招募不适用

Evaluation of the Relationship Between 0-24-Hour Fraction of Inspired Oxygen (FiO₂) Exposure and Changes in the Uric Acid/Albumin Ratio in Intensive Care Unit Patients Diagnosed With Sepsis

Istinye University0 个研究点目标入组 110 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
主要终点
Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure

研究概览

简要总结

This prospective, non-interventional study aims to investigate the relationship between early oxygen exposure and oxidative stress in adult intensive care unit (ICU) patients diagnosed with sepsis or septic shock. Fraction of inspired oxygen (FiO₂) levels administered during the first 24 hours of ICU admission will be evaluated in relation to changes in the uric acid/albumin ratio (UAR), a biochemical marker reflecting oxidative burden and inflammation. Serum uric acid and albumin levels will be measured at ICU admission and at 24 hours, and the percentage change in UAR (ΔUAR%) will be calculated. Associations between FiO₂ exposure parameters and ΔUAR% will be analyzed, along with secondary outcomes including 28-day mortality and oxygenation indices. The findings may help clarify whether excessive oxygen therapy contributes to oxidative stress and whether UAR can serve as an accessible biomarker of oxygen-related oxidative injury in septic ICU patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years or older
  • Admission to the intensive care unit with a diagnosis of sepsis according to Sepsis-3 criteria
  • Receipt of oxygen therapy with FiO₂ ≥ 0.3 during ICU stay
  • Availability of serum uric acid, albumin, and lactate measurements and calculated SOFA scores at ICU admission
  • Availability of serum uric acid and albumin levels both at ICU admission (baseline) and at 24 hours
  • Provision of informed consent by the patient or a legally authorized representative

排除标准

  • Age younger than 18 years
  • Pregnant or breastfeeding women
  • Chronic kidney disease or receipt of renal replacement therapy
  • Advanced liver failure (Child-Pugh class C)
  • Receipt of albumin infusion within the previous 24 hours
  • Use of medications that affect uric acid metabolism (e.g., allopurinol, febuxostat, rasburicase)
  • History of active gout attack or malignancy-related hyperuricemia
  • Missing serum uric acid or albumin measurements at baseline or 24 hours
  • Inability to obtain informed consent from the patient or a legally authorized representative

结局指标

主要结局

Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure

时间窗: From ICU admission (0 hour) to 24 hours after admission

The primary outcome is the association between fraction of inspired oxygen (FiO₂) levels administered during the first 24 hours of intensive care unit admission and the change in the uric acid/albumin ratio (UAR). Serum uric acid and albumin levels will be measured at ICU admission (baseline) and at 24 hours, and the percentage change in UAR (ΔUAR%) will be calculated. Correlation analyses will be performed to evaluate the relationship between FiO₂ exposure parameters and ΔUAR%

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

İlke Dolgun

Assos.Prof.

Istinye University

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