Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen Exposure (Fraction of Inspired Oxygen, FiO₂) - Standard of Care (Observational, No Experimental Intervention).
- Who it may be relevant to
- Registry conditions: Hyperoxia / High FiO₂ Exposure, Uric Acid/Albumin Ratio (UAR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Other 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 observationa
Primary outcome measures
- Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure [Time frame: From ICU admission (0 hour) to 24 hours after admission]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Katakam SN, Cherukuri M, Kada M, Hanji P, Kudru CU. The Prognostic Significance of Serum Uric Acid in Sepsis: A Comparative Study on Adult Patients. Indian J Crit Care Med. 2025 May;29(5):407-412. doi: 10.5005/jp-journals-10071-24968. Epub 2025 May 8. PMID 40416537
- Ertan OES, Gokce O, Bal C, Kocaturk E, Ertan O, Mutluay R. Investigation of the Relationship Between Serum Uric Acid-to-Albumin Ratio and 28-Day Mortality in Patients With and Without Acute Kidney Injury. J Acute Med. 2024 Dec 1;14(4):152-159. doi: 10.6705/j.jacme.202412_14(4).0003. PMID 39624148
Identifiers
NCT: NCT07332637 · 329-2025