Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Euvolemic Hyponatremia, Hypervolemic Hyponatremia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyponatremia Patients<br>Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum sodium concentration from beginning of treatment period to the end of treatment period or discharge for a given hyponatremia treatment |  | Hospital Discharge | 
| Duration of hospital stay from time of first presentation of hyponatremia (which will be taken as the time of first presentation of hyponatremia for the current admission) to discharge |  | Hospital Discharge | 
| Time to initiation of hyponatremia treatment |  | Hospital Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative proportions of etiologies associated with hyponatremia |  | Hospital Discharge | 
| Profile of investigations performed in diagnosing hyponatremia |  | Hospital Discharge | 
| Therapies used in the management of hyponatremia |  | Hospital Discharge | 
| Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction. | Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction measured as one of the following: serum sodium >130 serum sodium ≥135 mmol/L increase of serum sodium ≥5 mmol/L | Hospital Discharge | 
| Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction. | Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction measured as one of the following: serum sodium >130 serum sodium ≥135 mmol/L increase of serum sodium ≥5 mmol/L | Hospital Discharge | 
| Effectiveness of individual therapies in achieving symptom improvement measured as the number of reported symptoms at the start and end of treatment with a specific therapy |  | Hospital Discharge | 
| Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay |  | Hospital Discharge | 
| Impact of hyponatremia on medically necessary length of stay |  | Hospital Discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyponatremia, Euvolemia, Hypervolemia, Euvolemic, Hypervolemic