Assessment of Kidney Function in Patients With Epilepsy

NCT ID: NCT07288788

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-28

Study Completion Date

2026-09-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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All Participants

Observational study of pediatric patients admitted to Sohag University Hospital

Standard Clinical Observation

Intervention Type BEHAVIORAL

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

Interventions

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Standard Clinical Observation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hassan Ahmed

Resident Physician, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University

Sohag, , Egypt

Site Status RECRUITING

Sohage Faculty of Medicine

Sohag, , Egypt

Site Status ACTIVE_NOT_RECRUITING

Countries

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Egypt

Central Contacts

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mohamed hassan hassan, resident

Role: CONTACT

Phone: 01146167336

Email: [email protected]

Facility Contacts

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mohamed hassan ahmed, MBBS

Role: primary

Other Identifiers

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Soh-Med--25-9-2MS

Identifier Type: -

Identifier Source: org_study_id