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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Observational study of pediatric patients admitted to Sohag University Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Clinical Observation | Behavioral | Observational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only. |
| 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) |
| 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 |
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Inclusion criteria
Exclusion criteria:
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Pediatric patients admitted to Sohag University Hospital. Observational data will be collected from medical records.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mohamed hassan hassan, resident | Contact | 01146167336 | Mohamedhassanfonn2@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Recruiting | Sohag | Egypt |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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) |
| Sohage Faculty of Medicine | Active, not recruiting | Sohag | Egypt |