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NCT Number: NCT07288788

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.

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Key information

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University, Sohag, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Clinical Observation

Behavioral

Observational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only.

Primary outcomes

  1. Serum creatinine level in pediatric epilepsy patients

    Time frame: At enrollment (single cross-sectional assessment)

    Measurement of serum creatinine in pediatric patients at enrollment to assess renal function related to epilepsy or antiepileptic drug use

Secondary outcomes

  1. Prevalence of nephrolithiasis / nephrocalcinosis

    Time frame: At enrollment (single cross-sectional assessment)

    Presence of renal calculi or nephrocalcinosis detected by abdominal ultrasound performed at enrollment.

  2. Electrolyte disturbances

    Time frame: At enrollment (single cross-sectional assessment)

    Frequency of clinically significant electrolyte abnormalities (e.g., hypokalemia, hypernatremia, bicarbonate reduction) measured in serum chemistry at enrollment.

  3. Abnormal urinalysis findings

    Time frame: At enrollment (single cross-sectional assessment)

    Proportion of participants with abnormal urine analysis results (proteinuria, hematuria, crystalluria, or other abnormalities) at enrollment.

  4. Association between AED regimen and renal parameters

    Time frame: At enrollment (single cross-sectional assessment)

    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.

  5. Abdominal Ultrasound Findings

    Time frame: At enrollment (single cross-sectional assessment)

    Detection of renal structural abnormalities including nephrolithiasis or nephrocalcinosis.

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed hassan hassan, resident

CONTACT

[email protected]

01146167336

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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