NCT01240668

Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

An Observational Prospective Registry to Identify Demographic and Clinical Characteristics of Patients Hospitalized With Euvolemic and Hypervolemic Hyponatremia and Assess the Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,028 (actual)
• Sponsor: Otsuka America Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Euvolemic Hyponatremia
• Hypervolemic Hyponatremia

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2010-11-15
• Last updated: 2015-05-15

Locations

79 sites across 3 countries: United States, Germany, United Kingdom