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Euvolemic Hyponatremia | Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

Euvolemic Hyponatremia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Euvolemic Hyponatremia

Hypervolemic Hyponatremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Hyponatremia PatientsEuvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L

Study Status

Completed

Start Date: September 2010

Completed Date: August 2013

Phase: N/A

Type: Observational

Design:

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

Secondary Outcome: Relative proportions of etiologies associated with hyponatremia

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Otsuka America Pharmaceutical

Collaborator: Registrat-Mapi

More information:https://clinicaltrials.gov/show/NCT01240668

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