Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia (HN Registry)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Euvolemic Hyponatremia Hypervolemic Hyponatremia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| 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 |
- Change in serum sodium concentration from beginning of treatment period to the end of treatment period or discharge for a given hyponatremia treatment [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Time to initiation of hyponatremia treatment [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Relative proportions of etiologies associated with hyponatremia [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Profile of investigations performed in diagnosing hyponatremia [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Therapies used in the management of hyponatremia [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction. [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
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 correcting hyponatremia and time taken to achieve the correction. [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
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 [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
- Impact of hyponatremia on medically necessary length of stay [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2505 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Hyponatremia Patients
Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The prospective registry study population will consist of up to 1500 patients at approximately 150 sites from the USA who are hospitalized and identified as having hypervolemic or euvolemic hyponatremia with serum sodium ≤130 mmol/L. Also up to 1005 patients at approximately 67 sites from Europe (United Kingdom, Germany, France, Italy, Spain, Denmark, and Sweden)who are identified as having hyponatremia ≤130mmol/L secondary to SIADH. A similar distribution of patients with a serum sodium <125 mmol/L and patients with a serum sodium between 125-130 mmol/L will be collected.
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
Contacts and Locations
Show 82 Study Locations More Information
No publications provided
| Responsible Party: | Sonnie Kim, Otsuka America Pharmaceutical, Inc |
| ClinicalTrials.gov Identifier: | NCT01240668 History of Changes |
| Other Study ID Numbers: | 156-10-292 |
| Study First Received: | November 11, 2010 |
| Last Updated: | April 21, 2011 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Conseil National de l'Ordre des Médecins France: French Data Protection Authority Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Sweden: Ethics Committee United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee Denmark: Danish Dataprotection Agency |
Keywords provided by Otsuka America Pharmaceutical:
|
Hyponatremia Euvolemia Hypervolemia Euvolemic Hypervolemic |
Additional relevant MeSH terms:
|
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013