Trial document




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  DRKS00006251

Trial Description

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Title

Diagnostic value of copeptin in febrile seizures

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Trial Acronym

EpiCop

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cerebral seizures are common in children, about 6 % of all children undergo at least one episode with cerebral seizure during their childhood. The most frequent and well-known type of seizures are febrile seizures, particularly in children younger than six years of age. Why just a small part of children with fever develop febrile seizures is widely unknown. The purpose of the study is to evaluate the diagnostic value of different biomarkes in febrile seizures. First we want to analyse a messenger substance regulating important body functions as blood pressure and water excretion (vasopressin). Therefore we investigate a decomposition product of this messenger (copeptin), which is more stable as the messenger itself. In addition, we want to evaluate the correlation between copeptin and the von Willebrand factor, the von Willebrand multimers and the von Willebrand collagen binding activity. These are important elements for blood coagulation.
The aim of our study is to identify the value of copeptin and the von Willebrand diagnostic in children younger than 6 years of age with febrile seizures und in children younger than six years of age without seizures but with fever (control group). We want to examine if a correlation exists between the occurrence of seizures, the severity of seizures, and the blood level of copeptin and the von Willebrand data compared to a control group with fever but without seizures.

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Brief Summary in Scientific Language

Cerebral seizures are common in children, about 6 % of all children undergo at least one episode with cerebral seizure during their childhood. The most frequent and well-known type of seizures are febrile seizures, particularly in children younger than six years of age. So far, the cause of the development of febrile seizures is not completely understood. The aim of our study is to evaluate the diagnostic value of copeptin in children younger than six years of age with cerebral seizures including febrile seizures compared to a control group with children younger than six years of age with fever but without seizures. Copeptin is a stable decomposition product of vasopressin. Furhtermore, there is a correlation between the release of vasopressin and the von Willebrand factor, the von Willebrand multimers, and the von Willebrand collagen binding activity. A further aim of our study is to evaluate if there is a correlation between the blood level of copeptin and the von Willebrand data in children with febrile seizures. In summary, the aim of this study is to examine if a correlation exists between the occurrence of seizures, the severity of seizures, and the blood level of copeptin and the von Willebrand data compared to a control group with fever but without seizures.

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Organizational Data

  •   DRKS00006251
  •   2014/06/23
  •   [---]*
  •   yes
  •   Approved
  •   137/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   [---]* 
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Health Condition or Problem studied

  •   R56.0 -  Febrile convulsions
  •   cerebral seizures,
    febrile infection (e. g. with focus in the airways or in the gastrointestinal tract)
  •   B99 -  Other and unspecified infectious diseases
  •   R56.8 -  Other and unspecified convulsions
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Interventions/Observational Groups

  •   Identification of the diagnostic value of copeptin and von Willebrand factor, von Willebrand collagen binding activity and von Willebrand multimers in children with cerebral seizures including febrile seizures
  •   Identification of the diagnostic value of copeptin and von Willebrand factor, von Willebrand collagen binding activity and von Willebrand multimers in children without cerebral seizures but with fever, as control group
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Copeptin serum level in children with febrile seizures presenting at our emergency ward compared to children with fever but without seizures

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Secondary Outcome

1) Copeptin serum level after febrile seizures compared to cerebral seizures without fever
2) Blood pH in all patients compared to type of seizures and value of copeptin
3) Level of von Willebrand-factor and von Willebrand-multimers as well as von Willebrand collagen binding activity in children with febrile seizures compared to children with fever but without seizuers

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Countries of Recruitment

  •   Switzerland
  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/16
  •   350
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   6   Years
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Additional Inclusion Criteria

1) Children < 6 years presenting at the emergency unit with past or ongoing cerebral seizures.
2) Children < 6 years presenting at the emergency unit without cerebral seizures but with fever and medically indicated blood tests. Fever is defined as body temperature > 38°C measured at the emergency unit.

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Exclusion Criteria

No medically indicated blood tests at the emergency unit.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Marcus  Krüger 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.   Marcus  Krüger 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum Freiburg
    • Ms.  Dr.  Astrid   Pechmann 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.   Marcus  Krüger 
    • Mathildenstraße 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.