Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
NCT ID: NCT01240668
Last Updated: 2015-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5028 participants
OBSERVATIONAL
2010-09-30
2013-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Hyponatremia Patients
Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of investigational drug, biologic, or device during the study
18 Years
ALL
No
Sponsors
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Registrat-Mapi
OTHER
Otsuka America Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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North America Research Institute
Azusa, California, United States
Chrishard Medical Group
Inglewood, California, United States
UCLA
Los Angeles, California, United States
Regional Cardiology Associates
Sacramento, California, United States
Portercare Adventist Health System
Denver, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Memorial Healthcare System
Hollywood, Florida, United States
Jacksonville Cardiovascular Center
Jacksonville, Florida, United States
Kidney & HTN Specialists of Miami
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Florida Hospital
Orlando, Florida, United States
Coastal Nephrology Associates Research
Port Charlotte, Florida, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Joseph M Still Research Foundation, Inc
Augusta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Ochsner Multi-Organ Transplant Center
New Orleans, Louisiana, United States
Detroit Medical Center
Detroit, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Central Michigan Community Hospital
Mount Pleasant, Michigan, United States
Providence Park Hospital
Novi, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
Covenant Heart Specialists
Saginaw, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Saint Louis University Hosptial
St Louis, Missouri, United States
Creighton University
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Hypertenstion and Renal Group
Livingston, New Jersey, United States
St Joseph's Regional Medical Center
Paterson, New Jersey, United States
Princeton Hypertension Nephrology Associates
Princeton Junction, New Jersey, United States
Tufts New England Medical Center
Boston, New York, United States
Buffalo General Hospital
Buffalo, New York, United States
The Jamaica Hospital Medical Center
Jamaica, New York, United States
Winthrop-University Hospital
Mineola, New York, United States
Beth Israel Medical Center-Petrie Division
New York, New York, United States
Center for Liver Disease and Transplantation
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
NYU
New York, New York, United States
Rochester General
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
St Catherine of Siena Medical Center
Smithtown, New York, United States
Jack D. Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Piedmont Respiratory Research
Greensboro, North Carolina, United States
Mercy Hospital
Canton, Ohio, United States
University of Cinncinati
Cincinnati, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mercy Hospital Fairfield
Fairfield, Ohio, United States
Kettering Health Network
Kettering, Ohio, United States
Kidney Care Specialists
Kettering, Ohio, United States
St Elizabeth Health Center
Youngstown, Ohio, United States
NE Clinical Research Center
Bethlehem, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Heart Specialists of Lancaster PC
Eprata, Pennsylvania, United States
Laurel Health System
Mansfield, Pennsylvania, United States
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, United States
SC Nephrology & Hypertension Ctr
Orangeburg, South Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, United States
Baptist Hospital Downtown
San Antonio, Texas, United States
Renal Associates, PA
San Antonio, Texas, United States
Clinical Research and Consulting Centter
Fairfax, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
CAMC Institute Inc.
Charleston, West Virginia, United States
Evangelische Lungenklinik
Berlin, , Germany
Klinikum Chemnitz
Chemnitz, , Germany
Universitätsklinik Köln
Cologne, , Germany
Klinikum der Johann-Wolfgang-Goethe-Universität
Frankfurt, , Germany
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Countries
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Other Identifiers
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156-10-292
Identifier Type: -
Identifier Source: org_study_id
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