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

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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Key information

Conditions

Hyperoxia / High FiO₂ Exposure Hyperoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Uric Acid/Albumin Ratio (UAR)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

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

Time frame: 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%

Study contacts

Contact information is provided by the study sponsor or research team.

İLKE DOLĞUN

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 12, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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