Assessment of Kidney Function in Patients With Epilepsy

This observational cross-sectional study aims to assess kidney function in pediatric patients with epilepsy attending Sohag University Hospital. The study evaluates renal biochemical markers, urinalysis, liver functions, abdominal ultrasonography, and the possible renal effects of long-term antiepileptic drug (AED) therapy.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Standard Clinical Observation

Detailed Description

Epilepsy is one of the most common neurological disorders requiring long-term antiepileptic drug therapy. Many AEDs are metabolized hepatically but excreted renally, which may affect kidney function, especially with long-term use. Several AEDs-including topiramate, zonisamide, acetazolamide, carbamazepine, and valproate-have been associated with nephrolithiasis, tubular dysfunction, nephrotoxicity, and acute kidney injury.

The study evaluates renal function among children with idiopathic epilepsy using clinical assessment, laboratory markers (CBC, serum creatinine, electrolytes, ABG, urinalysis, liver functions), EEG findings, and abdominal ultrasound. The purpose is to estimate the prevalence of renal affection and its possible relation to AED use.

This observational cross-sectional study evaluates renal function in pediatric patients with epilepsy by measuring serum creatinine levels at the time of enrollment. The study will enroll children of various ages and both sexes, representing multiple epilepsy types and receiving different antiepileptic drug regimens.

Comprehensive baseline data, including demographic characteristics, medical history, seizure type and frequency, and current medication usage, will be collected. Venous blood samples will be obtained for serum creatinine measurement using validated clinical laboratory methods, ensuring standardized assessment of renal function.

The study's primary objective is to determine baseline renal function in this population and to investigate potential associations between antiepileptic drug therapy and renal outcomes. Secondary analyses will explore correlations between serum creatinine levels and patient-specific factors such as age, sex, epilepsy type, duration of therapy, and comorbidities.

All data will be handled in accordance with institutional and regulatory guidelines for clinical research. The results are intended to inform clinical monitoring practices, optimize antiepileptic drug management, and support future research on kidney function in children with epilepsy.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: mohamed hassan hassan, resident; Phone Number: 01146167336; Email: Mohamedhassanfonn2@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University
    • Contact: mohamed hassan ahmed, MBBS; Phone Number: 01146167336; Email: Mohamedhassanfonn2@gmail.com
  • Sohag, Egypt
    • Active, not recruiting
    • Sohage Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to Sohag University Hospital. Observational data will be collected from medical records.

Description

Inclusion criteria

• Age: children between 1month and 15years old.
• Both sexes.
• children who suffering from idiopathic epilepsy

Exclusion criteria:

• Age: children below 1month old& children above 15 years old.
• Children suffer from convulsions due to CNS infection
• Children with non idiobathic epilepsy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; Observational study of pediatric patients admitted to Sohag University Hospital	Behavioral: Standard Clinical Observation; Observational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine level in pediatric epilepsy patients	Measurement of serum creatinine in pediatric patients at enrollment to assess renal function related to epilepsy or antiepileptic drug use	At enrollment (single cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of nephrolithiasis / nephrocalcinosis	Presence of renal calculi or nephrocalcinosis detected by abdominal ultrasound performed at enrollment.	At enrollment (single cross-sectional assessment)
Electrolyte disturbances	Frequency of clinically significant electrolyte abnormalities (e.g., hypokalemia, hypernatremia, bicarbonate reduction) measured in serum chemistry at enrollment.	At enrollment (single cross-sectional assessment)
Abnormal urinalysis findings	Proportion of participants with abnormal urine analysis results (proteinuria, hematuria, crystalluria, or other abnormalities) at enrollment.	At enrollment (single cross-sectional assessment)
Association between AED regimen and renal parameters	Comparison of renal function markers (serum creatinine, urinalysis, ultrasound findings) across groups defined by type of antiepileptic drug(s) used (e.g., renally excreted vs. non-renally excreted drugs) at enrollment.	At enrollment (single cross-sectional assessment)
Abdominal Ultrasound Findings	Detection of renal structural abnormalities including nephrolithiasis or nephrocalcinosis.	At enrollment (single cross-sectional assessment)

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2025
• Primary Completion (Actual): September 28, 2025
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Soh-Med--25-9-2MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

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