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This study has been withdrawn prior to enrollment.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 )

First Received on March 1, 2006. Last Updated on July 11, 2007 History of Changes

Sponsor:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00298753

Purpose

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

Condition	Intervention	Phase
Syndrome of Inappropriate ADH-Secretion	Procedure: fluid restriction for 14 days (15ml fluid per kg weight)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-Secretion Caused by Treatment With Antiepileptic Medicine

Further study details as provided by Holstebro Hospital:

Estimated Enrollment:	30
Study Start Date:	May 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298753

Locations

Denmark
Department of Medicine, Holstebro Hospital
Holstebro, Jutland, Denmark, 7500

Sponsors and Collaborators

Holstebro Hospital

Investigators

Study Chair:

Erling B Pedersen, Professor

Holstebro Hospital, Denmark

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00298753 History of Changes
Other Study ID Numbers:	MED.RES.HOS.2005.04/IMT
Study First Received:	March 1, 2006
Last Updated:	July 11, 2007
Health Authority:	Denmark: Ethics Committee

Additional relevant MeSH terms:

Inappropriate ADH Syndrome
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Water-Electrolyte Imbalance

Metabolic Diseases
Endocrine System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012