Copeptin in Childhood Epilepsy (EpiCop)
|ClinicalTrials.gov Identifier: NCT01884766|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : September 19, 2017
|Condition or disease|
|Epilepsy Febrile Seizures Children|
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.
- Circulating copeptin concentrations are increased after generalized seizures, including FS.
- Copeptin is predictive for complexity and relapse in FS.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||340 participants|
|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
- Copeptin concentration in serum [ Time Frame: at admission ]
- base excess in blood gas analysis [ Time Frame: at admission ]
- prolactin [ 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 ]
- osmolality [ Time Frame: at admission ]
- hydrogen ion activity in blood gas analysis [ Time Frame: at admission ]hydrogen ion activity = pH
- number of repeated events of seizures [ Time Frame: 12 month ]relapse of seizures within 12 month
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884766
|University Children's Hospital Basel|
|Basel, Switzerland, 4056|
|Principal Investigator:||Sven Wellmann, MD||University Children's Hospital Basel, 4056 Basel, Switzerland|