Hyperoxia / High FiO₂ ExposureNCT07332637
Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU Patients
An observational study of Hyperoxia / High FiO₂ Exposure and Uric Acid/Albumin Ratio (UAR), run by Istinye University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia / High FiO₂ Exposure, Uric Acid/Albumin Ratio (UAR)
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Oxygen Exposure (Fraction of Inspired Oxygen, FiO₂) - Standard of Care (Observational, No Experimental Intervention)
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure
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%
Measured: From ICU admission (0 hour) to 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperoxia / High FiO₂ ExposureStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332637
- Sponsor's protocol ID
- 329-2025
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40416537Ertan 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.
PubMed 39624148
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07332637
- Acronym / sponsor ID
- 329-2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 observational, and collected data will be used to evaluate the association between FiO₂ exposure and changes in the uric acid/albumin ratio. | Other | – |
Primary outcome
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%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 40416537Katakam 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.
- Background: PubMed 39624148Ertan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperoxia / High FiO₂ Exposure and Uric Acid/Albumin Ratio (UAR), run by Istinye University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İLKE DOLĞUN (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure (time frame: From ICU admission (0 hour) to 24 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07332637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.