Is There Any Prognostic Value of Serum Uromodulin in Sepsis Induced AKI.

Serum Uromodulin Prognostic Value in Sepsis Induced AKI

To determine whether baseline (day 0; day of diagnosis),day 7 and on discharge serum uromodulin levels help predict clinical outcomes in adult patients with sepsis induced AKI.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury

Detailed Description

Sepsis remains a leading cause of morbidity and mortality worldwide, with risk rising as organs failure accumulate, particularly when acute kidney injury (AKI) develops. AKI complicates nearly half of all septic episodes in ICU and is independently associated with poorer short- and long-term outcomes. Current prognostic tools as SOFA score , serum creatinine, urine output, NGAL and KIM-1have limited prognostic value. They often detect injury only after significant damage has occurred.

Uromodulin, the most abundant urinary protein produced by the renal thick ascending limb, is present in small amounts in the circulation. Experimental models reveal that uromodulin deficiency worsens sepsis outcomes, while administration of exogenous uromodulin can reduce mortality . In clinical studies of septic patients, early rises in circulating uromodulin are observed, yet those who go on to develop AKI or die tend to have lower levels at presentation. Genetic analyses, however, have not definitively proven a causal protective role for baseline uromodulin.

It has roles in tubular protection, immune modulation, and infection control, These important physiological functions may translate into valuable prognostic tools that may aid in predicting clinical outcomes. Serum uromodulin may serve as an early indicator of both renal tubular integrity and host defence capacity-qualities not captured by existing markers. Assessing serum uromodulin at time of diagnosis(day 0), day 7 and at time of discharge may predict recovery or progression of AKI. Establishing the prognostic value of uromodulin could enable early risk stratification, guide tailored interventions, and inform clinical decision-making, potentially improving outcomes in sepsis-induced AKI.

• Study Type: Observational
• Enrollment (Estimated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People who is recently diagnosed with AKI due to sepsis meeting the previously mentioned criteria and doesn't have the exclusion criteria.

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Septic patients with AKI: Diagnosis of sepsis is based on combination of variables including Sepsis-3 criteria within 24 hours of ICU admission(suspected or confirmed infection on clinical , lab and imaging evidence , acute increase in SOFA score =>2 points( or presence of septic shock). The latter is defined by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia (Singer et al 2016).
3. Diagnosis of AKI according to KDIGO-criteria ( increase creatinine by =>0.3 mg/dl ( =>26.5 micmol/l ) within 48 hrs or increase cr =>1.5 × baseline within 7days or urine output < 0.5 ml / kg / hr for => 6hrs)
4. Informed consent obtained and in case patient is unable to sign the consent his next of kin or has power

Exclusion Criteria:

1. Patients diagnosed with ESRD or kidney transplantation
2. Other causes of AKI
3. Pregnancy related causes of AKI
4. Active immunosuppressive therapy (e.g., high-dose steroids, chemotherapy)
5. Patients with background of adult polycystic kidney disease
6. Patients with cardiac failure
7. Patients with solitary kidney because of small renal mass that could affect uromodulin level.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Uromodulin as a Predictor of Acute Kidney Injury Outcome in Septic Patients	To assess whether serum uromodulin levels measured at ICU admission (day 0), day 7, and at ICU discharge can predict AKI outcome (complete renal recovery versus progression to chronic kidney disease), length of ICU stay, and 30-day all-cause mortality in adult patients with sepsis-induced acute kidney injury.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
2.1.Correlation Between Serum Uromodulin Levels and Need for Renal Replacement Therapy. 2.2.Correlation Between Serum Uromodulin Levels and SOFA Score. 2.3.Correlation Between Serum Uromodulin Levels and AKI Severity.	From ICU admission to ICU discharge.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Serum uromodulin
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: Uromodulin in AKI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No