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

NCT07332715 | Not Yet Recruiting

• 1 other identifier: 330-2025
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Sepsis-Related Mortality

Outcome Measures

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.

  Within the first 7 days following intensive care unit admission

Interventions

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

İLKE DOLĞUN

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos.Prof.

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

TU (1)