Copeptin in Childhood Epilepsy (EpiCop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884766
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : September 19, 2017
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease
Epilepsy Febrile Seizures Children

Detailed Description:


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:

  1. 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.
  2. 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.

Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Study on Copeptin in Childhood Epilepsy
Study Start Date : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2017

All kind of epilepsy, including febrile seizures
children without seizures at presentation in the emergency but fever due to banal infections

Primary Outcome Measures :
  1. Copeptin concentration in serum [ Time Frame: at admission ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. number of repeated events of seizures [ Time Frame: 12 month ]
    relapse of seizures within 12 month

Biospecimen Retention:   Samples Without DNA

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children below six years presenting at the emergency unit of one tertiary university children's hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01884766

University Children's Hospital Basel
Basel, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Principal Investigator: Sven Wellmann, MD University Children's Hospital Basel, 4056 Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01884766     History of Changes
Other Study ID Numbers: EKBB 352/12
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Seizures, Febrile
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms