Copeptin in Childhood Epilepsy

Epilepsy Clinical Trial

— EpiCop  

Official title:

Prospective Study on Copeptin in Childhood Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884766
• Other study ID #: EKBB 352/12
• Status: Completed
• Phase: N/A
• First received: May 10, 2013
• Last updated: September 18, 2017
• Start date: April 2013
• Est. completion date: March 2017

Study information

• Verified date: September 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: March 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Epilepsy
• Febrile Seizures
• Seizures
• Seizures, Febrile

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of repeated events of seizures	relapse of seizures within 12 month	12 month
Primary	Copeptin concentration in serum		at admission
Secondary	base excess in blood gas analysis		at admission
Secondary	prolactin		at admission
Secondary	duration of seizures		at admission
Secondary	Short term relapse of seizures		24 hours after first presentation
Secondary	sodium concentration		at admission
Secondary	osmolality		at admission
Secondary	hydrogen ion activity in blood gas analysis	hydrogen ion activity = pH	at admission