Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU … (NCT07332637) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU Patients
110 participantsStarted 2026-01-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure
Timeframe: From ICU admission (0 hour) to 24 hours after admission