Status:
COMPLETED
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
Lead Sponsor:
Otsuka America Pharmaceutical
Collaborating Sponsors:
Registrat-Mapi
Conditions:
Euvolemic Hyponatremia
Hypervolemic Hyponatremia
Eligibility:
All Genders
18+ years
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- Patients with hypovolemic hyponatremia
- Use of investigational drug, biologic, or device during the study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
5028 Patients enrolled
Trial Details
Trial ID
NCT01240668
Start Date
September 1 2010
End Date
August 1 2013
Last Update
May 15 2015
Active Locations (79)
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1
North America Research Institute
Azusa, California, United States
2
Chrishard Medical Group
Inglewood, California, United States
3
UCLA
Los Angeles, California, United States
4
Regional Cardiology Associates
Sacramento, California, United States