Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine

This study has been withdrawn prior to enrollment.
(no patients could be recruited)
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00298753
First received: March 1, 2006
Last updated: July 11, 2007
Last verified: September 2006

March 1, 2006
July 11, 2007
May 2005
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Complete list of historical versions of study NCT00298753 on ClinicalTrials.gov Archive Site
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Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine
Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine

Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that these patients have a higher reabsorption of water during the Aquaporine2 water channels,a higher concentration of Vasopressine (AVP), and a lower clearance of water.This situation will tend to normalize, when the patients are treated with fluid restriction

The purpose of the study is to determine the amount of Aquaporine2(AQP2)in the urine in patients treated with the antiepileptic drug Oxcarbazepine before and after the administration of fluid restriction

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Syndrome of Inappropriate ADH-Secretion
Procedure: fluid restriction for 14 days (15ml fluid per kg weight)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
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Inclusion Criteria:

Age more than 18 years, both men and women, patients with epilepsia treated with Oxcarbazepine, and a Sodium content in plasma lower than 130 mmol/liter

Exclusion Criteria:

severe diseases in the heart, lungs or liver;diabetes mellitus, other not-well treated diseases in endocrine organs, cancer; unwillingness to participate

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00298753
MED.RES.HOS.2005.04/IMT
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Regional Hospital Holstebro
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Study Chair: Erling B Pedersen, Professor Holstebro Hospital, Denmark
Regional Hospital Holstebro
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP