Trial record 6 of 40 for:    Febrile Seizures

Copeptin in Childhood Epilepsy (EpiCop)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01884766
First received: May 10, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition
Epilepsy
Febrile Seizures
Children

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study on Copeptin in Childhood Epilepsy

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Copeptin concentration in serum [ Time Frame: at admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • base excess in blood gas analysis [ Time Frame: at admission ] [ Designated as safety issue: No ]
  • prolactin [ Time Frame: at admission ] [ Designated as safety issue: No ]
  • duration of seizures [ Time Frame: at admission ] [ Designated as safety issue: No ]
  • Short term relapse of seizures [ Time Frame: 24 hours after first presentation ] [ Designated as safety issue: No ]
  • sodium concentration [ Time Frame: at admission ] [ Designated as safety issue: No ]
  • osmolality [ Time Frame: at admission ] [ Designated as safety issue: No ]
  • hydrogen ion activity in blood gas analysis [ Time Frame: at admission ] [ Designated as safety issue: No ]
    hydrogen ion activity = pH


Other Outcome Measures:
  • number of repeated events of seizures [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    relapse of seizures within 12 month


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 350
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epilepsy
All kind of epilepsy, including febrile seizures
Control
children without seizures at presentation in the emergency but fever due to banal infections

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.
  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884766

Contacts
Contact: Sven Wellmann, MD sven.wellmann@ukbb.ch
Contact: Benjamin Stoecklin, MD

Locations
Switzerland
University Children's Hospital Basel Recruiting
Basel, Switzerland, 4056
Contact: Benjamin Stoecklin, MD       benjamin.stoecklin@ukbb.ch   
Sub-Investigator: Benjamin Stoecklin, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Investigators
Principal Investigator: Sven Wellmann, MD University Children's Hospital Basel, 4056 Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01884766     History of Changes
Other Study ID Numbers: EKBB 352/12
Study First Received: May 10, 2013
Last Updated: June 20, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Seizures, Febrile
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014