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

January 12, 2026 updated by: İlke Dolgun, Istinye University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who are admitted to a tertiary-level intensive care unit with a diagnosis of sepsis or septic shock according to Sepsis-3 criteria. All included patients receive oxygen therapy as part of standard clinical care, with a fraction of inspired oxygen (FiO₂) of at least 0.3 during the early phase of ICU admission. The population represents critically ill patients requiring close monitoring, respiratory support, and comprehensive laboratory evaluation. Patients with conditions or treatments that may independently affect uric acid or albumin metabolism are excluded to allow a clearer assessment of the relationship between oxygen exposure and changes in the uric acid/albumin ratio.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
From ICU admission (0 hour) to 24 hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 329-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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