Copeptin in Childhood Epilepsy

NCT01884766 | Completed DMC

• 1 other identifier: EKBB 352/12
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Febrile Seizures; Children

Outcome Measures

Primary Outcomes (1)

• Copeptin concentration in serum

  at admission

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• number of repeated events of seizures

  12 month

Study Arms (2)

Epilepsy

All kind of epilepsy, including febrile seizures

Control

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

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children below six years presenting at the emergency unit of one tertiary university children's hospital

You may qualify if:

• All kind of seizures leading to presentation
• Age below 6 years
• Fever without seizures caused by banal infections
• Age below 6 years

You may not qualify if:

• No blood required for medical reasons

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Children's Hospital Basel: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, 4056, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25894585 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Epilepsy; Seizures, Febrile

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sven Wellmann, MD

  University Children's Hospital Basel, 4056 Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: June 24, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

CH (1)