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Not yet recruitingNCT07332715Updated Jan 13, 2026

Predictive Value of the Uric Acid/Albumin Ratio and Lactate in Sepsis Patients

An observational study in Sepsis-Related Mortality and Acute Kidney Injury, sponsored by Istinye University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Istinye University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
65 Years and older
Sex
All
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Study summary

Sepsis is a life-threatening condition characterized by organ dysfunction resulting from a dysregulated host response to infection and remains a leading cause of morbidity and mortality in intensive care units. Early identification of patients at high risk for adverse outcomes is essential for timely intervention and improved prognosis.

This prospective, single-center, non-interventional study aims to evaluate the predictive value of the combined use of the blood uric acid/albumin ratio (UAR) and serum lactate levels in patients aged 65 years and older who are admitted to the intensive care unit with a diagnosis of sepsis according to SEPSIS-3 criteria. Patients without acute kidney injury at admission and with at least 24 hours of intensive care follow-up will be included.

The primary outcome is the development of acute kidney injury within the first 7 days of ICU admission according to KDIGO criteria. Secondary outcomes include vasopressor requirement during ICU stay, changes in serum lactate levels over the first 24 hours, and 28-day mortality. The study seeks to determine whether the combination of UAR and lactate levels can serve as an easily accessible and clinically applicable biomarker to predict adverse outcomes and support prognostic assessment and treatment strategies in sepsis patients.

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Conditions studied

  • Sepsis-Related Mortality
  • Acute Kidney Injury

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In context

Acute Kidney Injury

1,596 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 80 is below the median of 151 across 774 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of critically ill adult patients aged 65 years and older who are admitted to a tertiary-level intensive care unit with a diagnosis of sepsis based on SEPSIS-3 criteria. All participants are required to have baseline measurements of serum uric acid, albumin, and lactate levels at the time of ICU admission and no evidence of acute kidney injury at presentation. The study focuses on evaluating the prognostic value of routinely available biochemical markers in predicting adverse clinical outcomes, including acute kidney injury, vasopressor requirement, and short-term mortality during intensive care follow-up.

Inclusion criteria

  • Patients aged 65 years and older
  • Diagnosis of sepsis according to SEPSIS-3 criteria
  • Admission to the intensive care unit
  • No acute kidney injury at admission according to KDIGO classification
  • Measurement of serum uric acid, albumin, and lactate levels at ICU admission
  • SOFA score calculated at ICU admission
  • ICU follow-up of at least 24 hours

Exclusion criteria

Exclusion Criteria:

  • Age under 65 years
  • Uncompensated or decompensated chronic liver disease (e.g., Child-Pugh class C)
  • Chronic kidney disease stage 4 or 5 (eGFR \<30 mL/min/1.73 m²)
  • Presence of acute kidney injury at admission according to KDIGO criteria
  • Active malignancy or receipt of active cancer treatment within the last 6 months
  • Missing or incomplete clinical/laboratory data
  • ICU follow-up less than 24 hours
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • OtherNon-interventional / Observational Study

    This is a non-interventional, observational study. No diagnostic or therapeutic intervention will be applied beyond routine clinical care. Blood uric acid, albumin, and serum lactate levels measured as part of standard intensive care management will be recorded at admission, and lactate levels will be reassessed at 24 hours. Patients will be followed prospectively during their intensive care stay to evaluate the development of acute kidney injury, vasopressor requirement, and 28-day mortality.

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What researchers measure

Primary outcomes

  1. Development of Acute Kidney Injury (AKI)

    Occurrence of acute kidney injury defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria in patients with sepsis admitted to the intensive care unit.

    Time frame: Within the first 7 days following intensive care unit admission

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Study locations

1 site
  • Istinye Üniversity
    Istanbul, Merkez Mahallesi 34250, Turkey (Türkiye)
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References and documents

Publications

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. PubMed 26903338 ↗
  • Barichello T, Generoso JS, Singer M, Dal-Pizzol F. Biomarkers for sepsis: more than just fever and leukocytosis-a narrative review. Crit Care. 2022 Jan 6;26(1):14. doi: 10.1186/s13054-021-03862-5. PubMed 34991675 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07332715
Lead sponsor
Istinye University
Responsible party
İlke Dolgun (Assos.Prof., Istinye University) — Principal investigator
First posted
Jan 12, 2026
Start date
Jan 15, 2026 (estimated)
Primary completion
May 15, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Jan 13, 2026

Study contacts

İLKE DOLĞUN
Contact
ilkeser2004@gmail.com
+905555485632

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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