Copeptin in Childhood Epilepsy
Prospective Study on Copeptin in Childhood Epilepsy
Sponsors |
Lead Sponsor: University Hospital, Basel, Switzerland Collaborator: University Children's Hospital Basel |
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Source | University Hospital, Basel, Switzerland | ||||||||||||||||
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. |
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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. |
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Overall Status | Completed | ||||||||||||||||
Start Date | April 2013 | ||||||||||||||||
Completion Date | March 2017 | ||||||||||||||||
Primary Completion Date | December 2015 | ||||||||||||||||
Study Type | Observational | ||||||||||||||||
Primary Outcome |
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Secondary Outcome |
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Enrollment | 340 | ||||||||||||||||
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Eligibility |
Sampling Method: Non-Probability Sample
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 Gender: All Minimum Age: N/A Maximum Age: 5 Years Healthy Volunteers: No |
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Overall Official |
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Location |
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Location Countries |
Switzerland |
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Verification Date |
September 2017 |
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Responsible Party |
Type: Sponsor |
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Has Expanded Access | No | ||||||||||||||||
Condition Browse | |||||||||||||||||
Arm Group |
Label: Epilepsy Description: All kind of epilepsy, including febrile seizures Label: Control Description: children without seizures at presentation in the emergency but fever due to banal infections |
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Acronym | EpiCop | ||||||||||||||||
Study Design Info |
Observational Model: Other Time Perspective: Prospective |