This trial is active, not recruiting.

Conditions epilepsy, febrile seizures, children
Sponsor University Hospital, Basel, Switzerland
Collaborator University Children's Hospital Basel
Start date April 2013
End date December 2016
Trial size 340 participants
Trial identifier NCT01884766, EKBB 352/12


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

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

Primary Outcomes

Copeptin concentration in serum
time frame: at admission

Secondary Outcomes

base excess in blood gas analysis
time frame: at admission
time frame: at admission
duration of seizures
time frame: at admission
Short term relapse of seizures
time frame: 24 hours after first presentation
sodium concentration
time frame: at admission
time frame: at admission
hydrogen ion activity in blood gas analysis
time frame: at admission

Eligibility Criteria

Male or female participants up to 5 years old.

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

Additional Information

Official title Prospective Study on Copeptin in Childhood Epilepsy
Principal investigator Sven Wellmann, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.