Copeptin in Childhood Epilepsy | NCT01884766

Studies
Copeptin in Childhood Epilepsy

NCT01884766

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Sep 19, 2017Actual

Enrollment

340Actual

Phase

Not provided

Conditions

Epilepsy
Febrile Seizures
Children

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Mar 2017Actual

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

Jun 20, 2013

First Posted Date

Jun 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2017

Last Update Posted Date

Sep 19, 2017Actual

Name	Class
University Children's Hospital Basel	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Circulating copeptin concentrations are increased after generalized seizures, including FS.
Copeptin is predictive for complexity and relapse in FS.

Specific aims:

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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epilepsy		All kind of epilepsy, including febrile seizures
Control		children without seizures at presentation in the emergency but fever due to banal infections

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Copeptin concentration in serum		at admission

Secondary Outcomes

Measure	Description	Time Frame
base excess in blood gas analysis		at admission
prolactin		at admission
duration of seizures

Other Outcomes

Measure	Description	Time Frame
number of repeated events of seizures	relapse of seizures within 12 month	12 month

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven Wellmann, MD	University Children's Hospital Basel, 4056 Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital Basel		Basel		4056	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25894585	Derived	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.

ID	Term
D004827	Epilepsy
D003294	Seizures, Febrile

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D012640	Seizures