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
We found this trial at
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Atlanta, Georgia 30342
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Azusa, California 91702
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Bronx, New York
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
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Buffalo, New York
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Charleston, West Virginia 25304
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Chattanooga, Tennessee 37404
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Cincinnati, Ohio
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2500 Metrohealth Dr
Cleveland, Ohio 44109
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Detroit, Michigan 48201
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Detroit, Michigan 48202
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Fairfield, Ohio 45014
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Greensboro, North Carolina
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Hollywood, Florida
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Jacksonville, Florida 32216
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Jamaica, New York 11418
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Kettering, Ohio 45429
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Mansfield, Pennsylvania
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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259 1st St
Mineola, New York 11501
(516) 663-0333
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701 Park Ave
Minneapolis, Minnesota 55415
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Mt Pleasant, Michigan 48858
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Naples, Florida 34102
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Nashville, Tennessee 37205
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NYU
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Novi, Michigan 48374
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
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Owensboro, Kentucky 42303
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Paterson, New Jersey 07503
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Petoskey, Michigan 49770
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Princeton Junction, New Jersey
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
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1250 E. Marshall St.
Richmond, Virginia 23298
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Rochester, New York
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Sacramento, California 95819
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San Antonio, Texas 78205
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
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