Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia



Status:Completed
Conditions:Metabolic
Therapuetic Areas:Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:September 2010
End Date:March 2012

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An Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized With Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization

The registry is a multi-center, prospective, observational study designed to collect data in
patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and
hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The
registry is observational in design, and the registry will collect data on patients with a
serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the
duration of the hospital, from admission to discharge, and the data will be entered into the
case report form (CRF) or into an electronic data capture (EDC) system. These patients will
be entered into the registry over the duration of 18 months at community, tertiary, and
academic medical centers from diverse multiple regions of the USA and Europe.

A patient's treatment will be determined by their caregiver and not by this protocol. Thus,
the registry will provide a unique opportunity to evaluate how the patients are managed
under real-world management conditions.


Inclusion Criteria:

- Adults ≥18 years old who are hospitalized

- Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L

- For euvolemic hyponatremia:

- Euvolemia is defined as: absence of clinical and historical evidence of
extracellular fluid volume depletion or sequestration; and absence of edema and
ascites; or

- Physician diagnosis of SIADH

- For hypervolemic hyponatremia (applies to USA sites only):

- Hypervolemia is defined as: excess extracellular fluid volume manifesting as
dependent edema or ascites

- Patients may have one or more of the following underlying co-morbid conditions:

- Congestive heart failure

- Cirrhosis and/or liver failure

- Nephrotic syndrome

Exclusion Criteria:

- Patients with hypovolemic hyponatremia

- Use of investigational drug, biologic, or device during the study
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Jacksonville, Florida 32216
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3550 Jerome Avenue
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3500 Gaston Avenue
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Durham, North Carolina 27710
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1800 West Charleston Boulevard
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1 Gustave L Levy Pl # 504
New York, New York 10029
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601 E Rollins St
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60 Crittenden Blvd # 70
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Chattanooga, Tennessee 37404
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251 E Huron St
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1653 W. Congress Parkway
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2500 Metrohealth Dr
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30 Prospect Ave
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Los Angeles, California 90095
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2160 South 1st Avenue
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259 1st St
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701 Park Ave
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600 Gresham Dr
Norfolk, Virginia 23507
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Novi, Michigan 48374
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2500 California Plaza
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1250 E. Marshall St.
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3800 Reservoir Rd NW
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