NCT07295392

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

December 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

December 8, 2025

Last Update Submit

December 26, 2025

Conditions

Keywords

Serum uromodulin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 18 years
  • 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).
  • 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)
  • Informed consent obtained and in case patient is unable to sign the consent his next of kin or has power

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resistant doctor in internal medicine department at Assiut university

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 19, 2025

Study Start

March 10, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12