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Assessment of Kidney Function in Patients With Epilepsy

Assessment of Kidney Function in Patients With Epilepsy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07288788
Enrollment
100
Registered
2025-12-17
Start date
2025-09-28
Completion date
2026-09-28
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

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.

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.

Interventions

BEHAVIORALStandard Clinical Observation

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum creatinine level in pediatric epilepsy patientsAt 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

MeasureTime frameDescription
Prevalence of nephrolithiasis / nephrocalcinosisAt enrollment (single cross-sectional assessment)Presence of renal calculi or nephrocalcinosis detected by abdominal ultrasound performed at enrollment.
Electrolyte disturbancesAt enrollment (single cross-sectional assessment)Frequency of clinically significant electrolyte abnormalities (e.g., hypokalemia, hypernatremia, bicarbonate reduction) measured in serum chemistry at enrollment.
Abnormal urinalysis findingsAt enrollment (single cross-sectional assessment)Proportion of participants with abnormal urine analysis results (proteinuria, hematuria, crystalluria, or other abnormalities) at enrollment.
Association between AED regimen and renal parametersAt 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.
Abdominal Ultrasound FindingsAt enrollment (single cross-sectional assessment)Detection of renal structural abnormalities including nephrolithiasis or nephrocalcinosis.

Countries

Egypt

Contacts

Primary Contactmohamed hassan hassan, resident
Mohamedhassanfonn2@gmail.com01146167336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026