Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

Otsuka America Pharmaceutical5,028 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,028

Conditions

Euvolemic Hyponatremia Hypervolemic Hyponatremia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (79)

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

Outcomes

Primary Outcomes

Change in serum sodium concentration from beginning of treatment period to the end of treatment period or discharge for a given hyponatremia treatment