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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01884766
Other study ID # EKBB 352/12
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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