Euvolemic Hyponatremia, Hypervolemic Hyponatremia
Conditions
Keywords
Hyponatremia, Euvolemia, Hypervolemia, Euvolemic, Hypervolemic
Brief 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.
Interventions
None listed
Sponsors
Registrat-Mapi
Otsuka America Pharmaceutical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction. | Hospital Discharge | 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 |
| 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 | — |
| Relative proportions of etiologies associated with hyponatremia | Hospital Discharge | — |
| Impact of hyponatremia on medically necessary length of stay | Hospital Discharge | — |
| Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay | Hospital Discharge | — |
| Profile of investigations performed in diagnosing hyponatremia | Hospital Discharge | — |
| Therapies used in the management of hyponatremia | Hospital Discharge | — |
Countries
Germany, United Kingdom, United States
Outcome results
None listed