Assessment of Kidney Function in Patients With Epilepsy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Standard Clinical Observation.
- Кому может быть актуально
- Состояния в реестре: Epilepsy. Базовые параметры: 1 мес. — 15 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Standard Clinical Observation
Observational study of pediatric patients admitted to Sohag University Hospital. No experimental treatment or device is administered. Data collection only.
Первичные конечные точки
- Serum creatinine level in pediatric epilepsy patients [Срок оценки: At enrollment (single cross-sectional assessment)]
Вторичные конечные точки (5)
- Prevalence of nephrolithiasis / nephrocalcinosis [Срок оценки: At enrollment (single cross-sectional assessment)]
- Electrolyte disturbances [Срок оценки: At enrollment (single cross-sectional assessment)]
- Abnormal urinalysis findings [Срок оценки: At enrollment (single cross-sectional assessment)]
- Association between AED regimen and renal parameters [Срок оценки: At enrollment (single cross-sectional assessment)]
- Abdominal Ultrasound Findings [Срок оценки: At enrollment (single cross-sectional assessment)]
Критерии участия
Критерии включения
- Age: children between 1month and 15years old.
- Both sexes.
- children who suffering from idiopathic epilepsy
Критерии исключения
- Age: children below 1month old\& children above 15 years old.
- Children suffer from convulsions due to CNS infection
- Children with non idiobathic epilepsy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Египет · 2 центра
- Sohag University — Sohag
- Sohage Faculty of Medicine — Sohag
Идентификаторы
NCT: NCT07288788 · Soh-Med--25-9-2MS