- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332715
Predictive Value of the Uric Acid/Albumin Ratio and Lactate in Sepsis Patients
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
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Merkez Mahallesi
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Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Within the first 7 days following intensive care unit admission
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 330-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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