Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia (HN Registry)

Otsuka

Status: Completed

Conditions: Euvolemic Hyponatremia; Hypervolemic Hyponatremia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01240668

156-10-292

Details and patient eligibility

About

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.

Enrollment: 5,028 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,028 participants in 1 patient group

Hyponatremia Patients

Description:

Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L