Clinical Trial: Copeptin in Childhood Epilepsy
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Prospective Study on Copeptin in Childhood Epilepsy
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 Summary:
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:
- Circulating copeptin concentrations are increased after generalized seizures, including FS.
- Copeptin is predictive for complexity and relapse in FS.
Specific aims:
- 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.
Sponsor: University Hospital, Basel, Switzerland
Current Primary Outcome: Copeptin concentration in serum [ Time Frame: at admission ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: University Hospital, Basel, Switzerland
Dates:
Date Received: May 10, 2013
Date Started: April 2013
Date Completion: July 2017
Last Updated: January 23, 2017
Last Verified: January 2017
