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NCT Number: NCT07332715

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-interventional / Observational Study

Other

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 outcomes

  1. Development of Acute Kidney Injury (AKI)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

İLKE DOLĞUN

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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