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Not yet recruiting NCT07332715

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

Observational Sepsis-Related Mortality Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-interventional / Observational Study.
Who it may be relevant to
Registry conditions: Sepsis-Related Mortality, Acute Kidney Injury. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Predictive Value of the Combination of Uric Acid/Albumin Ratio and Lactate for Acute Kidney Injury, Hemodynamic Support Requirement, and Mortality in Patients With Sepsis

Overview

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.

Interventions

  • Other Non-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.

Primary outcome measures

  • Development of Acute Kidney Injury (AKI) [Time frame: Within the first 7 days following intensive care unit admission]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

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. PMID 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. PMID 34991675

Identifiers

NCT: NCT07332715 · 330-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗