Copeptin in Childhood Epilepsy

NCT ID: NCT01884766

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-03-31

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.

Conditions

Epilepsy; Febrile Seizures; Children

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Epilepsy

All kind of epilepsy, including febrile seizures

No interventions assigned to this group

Control

children without seizures at presentation in the emergency but fever due to banal infections

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All kind of seizures leading to presentation
• Age below 6 years

• Fever without seizures caused by banal infections
• Age below 6 years

Exclusion Criteria

• No blood required for medical reasons

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sven Wellmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Basel, 4056 Basel, Switzerland

Locations

University Children's Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

Stocklin B, Fouzas S, Schillinger P, Cayir S, Skendaj R, Ramser M, Weber P, Wellmann S. Copeptin as a serum biomarker of febrile seizures. PLoS One. 2015 Apr 20;10(4):e0124663. doi: 10.1371/journal.pone.0124663. eCollection 2015.

Reference Type: DERIVED

PMID: 25894585 (View on PubMed)

Other Identifiers

EKBB 352/12

Identifier Type: -

Identifier Source: org_study_id