Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperoxia / High FiO₂ Exposure Uric Acid/Albumin Ratio (UAR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Oxygen Exposure (Fraction of Inspired Oxygen, FiO₂) - Standard of Care (Observational, No Experimental Intervention)

This study does not involve an experimental intervention. Patients will receive oxygen therapy as part of standard clinical care according to routine intensive care unit protocols and clinical indications. Fraction of inspired oxygen (FiO₂) levels administered during the first 24 hours of ICU admission will be recorded from ventilator and oxygen delivery system data. No changes will be made to patients' diagnostic, therapeutic, or oxygen administration practices. The study is purely observational, and collected data will be used to evaluate the association between FiO₂ exposure and changes in the uric acid/albumin ratio.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No