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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07332637
Enrollment
110
Registered
2026-01-12
Start date
2026-01-15
Completion date
2026-05-31
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

OTHEROxygen 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.

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ ExposureFrom ICU admission (0 hour) to 24 hours after admissionThe 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%

Contacts

Primary ContactİLKE DOLĞUN
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026