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临床试验/NCT01884766
NCT01884766已完成不适用

Prospective Study on Copeptin in Childhood Epilepsy

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
340
试验地点
1
主要终点
Copeptin concentration in serum

研究概览

简要总结

In many fields of medicine, except seizure disorders, blood biomarkers have captured an integrated part of diagnostic decision making, including copeptin, the surrogate marker of vasopressin release. There are strong arguments to hypothesize circulating copeptin is elevated in epilepsy, especially in generalized seizures such as fever seizures (FS), and that copeptin is predictive for complexity and relapse at least in FS. Although long-term morbidity and mortality are both low in FS, there is high anxiety among parents because of a lack of criterions to identify children at risk for relapse. Copeptin may fill this gap by adding important diagnostic and prognostic information. Eventually, less children may receive needlessly over years fever drugs or anti-epileptic drugs.

详细描述

Background:

Copeptin is a surrogate marker of the pituitary-secreted nonapeptide arginine-vasopressin (AVP) and has gradually replaced AVP in several clinical studies largely due to its structural and methodological advantages. Copeptin is a marker of non-specific stress response, and has been suggested to have clinical implications in a variety of cardiovascular and non-cardiovascular conditions. However, up to now there are no data available on copeptin in seizure disorders, neither in adults nor in children.

Working hypotheses:

  1. Circulating copeptin concentrations are increased after generalized seizures, including FS.
  2. Copeptin is predictive for complexity and relapse in FS.

Specific aims:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • No blood required for medical reasons

结局指标

主要结局

Copeptin concentration in serum

时间窗: at admission

次要结局

  • prolactin(at admission)
  • duration of seizures(at admission)
  • base excess in blood gas analysis(at admission)
  • Short term relapse of seizures(24 hours after first presentation)
  • sodium concentration(at admission)
  • osmolality(at admission)
  • hydrogen ion activity in blood gas analysis(at admission)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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