Copeptin in Childhood Epilepsy

Prospective Study on Copeptin in Childhood Epilepsy

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Collaborator: University Children's Hospital Basel

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.

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.

Overall Status Completed
Start Date April 2013
Completion Date March 2017
Primary Completion Date December 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Copeptin concentration in serum at admission
Secondary Outcome
Measure Time Frame
base excess in blood gas analysis at admission
prolactin at admission
duration of seizures at admission
Short term relapse of seizures 24 hours after first presentation
sodium concentration at admission
osmolality at admission
hydrogen ion activity in blood gas analysis at admission
Enrollment 340
Condition
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

Overall Official
Last Name Role Affiliation
Sven Wellmann, MD Principal Investigator University Children's Hospital Basel, 4056 Basel, Switzerland
Location
Facility: University Children's Hospital Basel
Location Countries

Switzerland

Verification Date

September 2017

Responsible Party

Type: Sponsor

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

Acronym EpiCop
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov