Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia - Full Text View

Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia (CONA)

This study is currently recruiting participants.

Verified by University of Wuerzburg, April 2008

Sponsored by:	University of Wuerzburg
Information provided by:	University of Wuerzburg
ClinicalTrials.gov Identifier:	NCT00541944

Purpose

The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.

Condition
Hyponatremia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

Establishment of an clinical algorithm to differentiate the different causes of hyponatremia [ Time Frame: One year ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum, plasma and urine

Estimated Enrollment:	120
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients treated in an University Hospital in Germany

Criteria

Inclusion Criteria:

hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg;
age > 18 years;
letter of agreement.

Exclusion Criteria:

gravidity and lactation;
restricted decision-making-ability

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541944

Contacts

Contact: Bruno Allolio, MD	49-931-201-36109	allolio_b@medizin.uni-wuerzburg.de
Contact: Wiebke Fenske, MD	49-931-201-36774	fenske_w@medizin.uni-wuerzburg.de

Locations

Germany
University of Wuerzburg	Recruiting
Wuerzburg, Germany, 97080
Contact: Bruno Allolio, MD
Contact: Wiebke Fenske, MD

Sponsors and Collaborators

University of Wuerzburg

Investigators

Principal Investigator:

Bruno Allolio, MD

Universtiy of Wuerzburg

More Information

Publications indexed to this study:

Fenske W, Störk S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. Epub 2008 May 13.

Study ID Numbers:	Wue-CONA-33/07
Study First Received:	October 9, 2007
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00541944
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Wuerzburg:

hyponatremia
diagnosis and treatment of hyponatremia
classification of hyponatremia

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Water-Electrolyte Imbalance
Metabolic disorder

ClinicalTrials.gov processed this record on January 14, 2009