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Copeptin in Childhood Epilepsy

Prospective Study on Copeptin in Childhood Epilepsy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01884766
Acronym
EpiCop
Enrollment
340
Registered
2013-06-24
Start date
2013-04-30
Completion date
2017-03-31
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Epilepsy, Febrile Seizures

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.

Detailed description

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: 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.

Interventions

None listed

Sponsors

University Children's Hospital Basel
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Copeptin concentration in serumat admission

Secondary

MeasureTime frameDescription
base excess in blood gas analysisat admission
prolactinat admission
duration of seizuresat admission
sodium concentrationat admission
osmolalityat admission
hydrogen ion activity in blood gas analysisat admissionhydrogen ion activity = pH
Short term relapse of seizures24 hours after first presentation

Other

MeasureTime frameDescription
number of repeated events of seizures12 monthrelapse of seizures within 12 month

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026