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Completed

NCT Number: NCT01884766

Copeptin in Childhood Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Children Febrile Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Seizures, Febrile Signs and Symptoms

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel

Basel, 4056, Switzerland

About this study

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:

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

Specific aims:

  • to determine copeptin concentrations in children below six years after generalized seizures, either unrelated or related to fever (FS), and in control children below six years without seizures.
  • to compare copeptin concentrations with blood-gas parameters (including hydrogen ion concentration (pH), base deficiency, and carbon dioxide), lactate, sodium, chloride, C reactive protein (CRP), and prolactin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

epilepsy-cohort:

  • All kind of seizures leading to presentation
  • Age below 6 years

Inclusion criteria

control-cohort:

  • Fever without seizures caused by banal infections
  • Age below 6 years

Exclusion criteria

  • No blood required for medical reasons

Treatment and study plan

Primary outcomes

  1. Copeptin concentration in serum

    Time frame: at admission

Secondary outcomes

  1. base excess in blood gas analysis

    Time frame: at admission

  2. prolactin

    Time frame: at admission

  3. duration of seizures

    Time frame: at admission

  4. Short term relapse of seizures

    Time frame: 24 hours after first presentation

  5. sodium concentration

    Time frame: at admission

  6. osmolality

    Time frame: at admission

  7. hydrogen ion activity in blood gas analysis

    Time frame: at admission

    hydrogen ion activity = pH

Other outcomes

  1. number of repeated events of seizures

    Time frame: 12 month

    relapse of seizures within 12 month

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University Children's Hospital Basel

Registry information

Official study title

Prospective Study on Copeptin in Childhood Epilepsy

Acronym: EpiCop

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Jun 24, 2013
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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