Copeptin in Childhood Epilepsy

Completed

• Conditions: Epilepsy; Febrile Seizures; Children

• Registration Number: NCT01884766
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-24
• Primary Completion: 2015-12
• Study Completion: 2017-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

• No blood required for medical reasons

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Copeptin concentration in serum	at admission

Secondary Outcome Measures

Name	Time	Method
prolactin	at admission
duration of seizures	at admission
base excess in blood gas analysis	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	hydrogen ion activity = pH

Trial Locations

Locations (1)

University Children's Hospital Basel; 🇨🇭 Basel, Switzerland