Euvolemic Hyponatremia Clinical Trial
Official title:
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
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT00876876 -
International, Multicenter, Open-Label and Randomized Withdrawal Study of Oral Lixivaptan in Heart Failure Patients With Chronic Hyponatremia
|
Phase 3 |