Copeptin in Childhood Epilepsy (EpiCop)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prospective Study on Copeptin in Childhood Epilepsy|
- Copeptin concentration in serum [ Time Frame: at admission ] [ Designated as safety issue: No ]
- base excess in blood gas analysis [ Time Frame: at admission ] [ Designated as safety issue: No ]
- prolactin [ Time Frame: at admission ] [ Designated as safety issue: No ]
- duration of seizures [ Time Frame: at admission ] [ Designated as safety issue: No ]
- Short term relapse of seizures [ Time Frame: 24 hours after first presentation ] [ Designated as safety issue: No ]
- sodium concentration [ Time Frame: at admission ] [ Designated as safety issue: No ]
- osmolality [ Time Frame: at admission ] [ Designated as safety issue: No ]
- hydrogen ion activity in blood gas analysis [ Time Frame: at admission ] [ Designated as safety issue: No ]hydrogen ion activity = pH
- number of repeated events of seizures [ Time Frame: 12 month ] [ Designated as safety issue: No ]relapse of seizures within 12 month
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
All kind of epilepsy, including febrile seizures
children without seizures at presentation in the emergency but fever due to banal infections
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01884766
|Contact: Sven Wellmann, MDemail@example.com|
|Contact: Benjamin Stoecklin, MD|
|University Children's Hospital Basel||Recruiting|
|Basel, Switzerland, 4056|
|Contact: Benjamin Stoecklin, MD firstname.lastname@example.org|
|Sub-Investigator: Benjamin Stoecklin, MD|
|Principal Investigator:||Sven Wellmann, MD||University Children's Hospital Basel, 4056 Basel, Switzerland|