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

NCT ID: NCT07332715

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis-Related Mortality Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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İlke Dolgun

Assos.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istinye Üniversity

Istanbul, Merkez Mahallesi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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İLKE DOLĞUN

Role: CONTACT

+905555485632

References

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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.

Reference Type RESULT
PMID: 26903338 (View on PubMed)

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.

Reference Type RESULT
PMID: 34991675 (View on PubMed)

Other Identifiers

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330-2025

Identifier Type: -

Identifier Source: org_study_id

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