Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

Completed

Conditions studied: Euvolemic Hyponatremia, Hypervolemic Hyponatremia

In brief

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.

Key facts

Study ID

NCT01240668

Run by

Otsuka America Pharmaceutical

People needed

5028

Starts

2010-09-01

Expected to finish

2013-08-01

Last updated by the study team

2015-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with hypovolemic hyponatremia
• Use of investigational drug, biologic, or device during the study

Where it is running

• 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
• North America Research Institute — Azusa, California, United States

Full record on ClinicalTrials.gov

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