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临床试验/NCT07288788
NCT07288788招募中不适用

Assessment of Kidney Function in Patients With Epilepsy

Sohag University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Serum creatinine level in pediatric epilepsy patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Month 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Serum creatinine level in pediatric epilepsy patients

时间窗: 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

次要结局

  • Electrolyte disturbances(At enrollment (single cross-sectional assessment))
  • Abnormal urinalysis findings(At enrollment (single cross-sectional assessment))
  • Prevalence of nephrolithiasis / nephrocalcinosis(At enrollment (single cross-sectional assessment))
  • Association between AED regimen and renal parameters(At enrollment (single cross-sectional assessment))
  • Abdominal Ultrasound Findings(At enrollment (single cross-sectional assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hassan Ahmed

Resident Physician, Pediatrics

Sohag University

研究点 (2)

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