Clinical trial NCT01884766: Copeptin in Childhood Epilepsy
Official title: Prospective Study on Copeptin in Childhood Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Febrile Seizures
Children
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2013-06-24
Enrollment: 340
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children below six years presenting at the emergency unit of one tertiary university children's hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Copeptin concentration in serum
timeFrame: at admission
Secondary outcomes:
measure: base excess in blood gas analysis
timeFrame: at admission
measure: prolactin
timeFrame: at admission
measure: duration of seizures
timeFrame: at admission
measure: Short term relapse of seizures
timeFrame: 24 hours after first presentation
measure: sodium concentration
timeFrame: at admission
measure: osmolality
timeFrame: at admission
measure: hydrogen ion activity in blood gas analysis
timeFrame: at admission
Other outcomes:
measure: number of repeated events of seizures
timeFrame: 12 month
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
Study officials:
affiliation: University Children's Hospital Basel, 4056 Basel, Switzerland
name: Sven Wellmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocklin B, Fouzas S, Schillinger P, Cayir S, Skendaj R, Ramser M, Weber P, Wellmann S. Copeptin as a serum biomarker of febrile seizures. PLoS One. 2015 Apr 20;10(4):e0124663. doi: 10.1371/journal.pone.0124663. eCollection 2015.