Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-26 @ 7:34 AM
Study NCT ID:
NCT01240668
Status:
COMPLETED
Last Update Posted:
2015-05-15
First Post:
2010-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5028}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2010-11-11', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum sodium concentration from beginning of treatment period to the end of treatment period or discharge for a given hyponatremia treatment', 'timeFrame': 'Hospital Discharge'}, {'measure': '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', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Time to initiation of hyponatremia treatment', 'timeFrame': 'Hospital Discharge'}], 'secondaryOutcomes': [{'measure': 'Relative proportions of etiologies associated with hyponatremia', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Profile of investigations performed in diagnosing hyponatremia', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Therapies used in the management of hyponatremia', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.', 'timeFrame': 'Hospital Discharge', 'description': 'Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction measured as one of the following:\n\nserum sodium \\>130 serum sodium ≥135 mmol/L increase of serum sodium ≥5 mmol/L'}, {'measure': 'Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.', 'timeFrame': 'Hospital Discharge', 'description': 'Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction measured as one of the following:\n\n* serum sodium \\>130\n* serum sodium ≥135 mmol/L\n* increase of serum sodium ≥5 mmol/L'}, {'measure': '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', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay', 'timeFrame': 'Hospital Discharge'}, {'measure': 'Impact of hyponatremia on medically necessary length of stay', 'timeFrame': 'Hospital Discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyponatremia', 'Euvolemia', 'Hypervolemia', 'Euvolemic', 'Hypervolemic'], 'conditions': ['Euvolemic Hyponatremia', 'Hypervolemic Hyponatremia']}, 'descriptionModule': {'briefSummary': "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.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years old who are hospitalized\n* Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L\n* For euvolemic hyponatremia:\n\n * Euvolemia is defined as: absence of clinical and historical evidence of extracellular fluid volume depletion or sequestration; and absence of edema and ascites; or\n * Physician diagnosis of SIADH\n* For hypervolemic hyponatremia (applies to USA sites only):\n\n * Hypervolemia is defined as: excess extracellular fluid volume manifesting as dependent edema or ascites\n * Patients may have one or more of the following underlying co-morbid conditions:\n\n * Congestive heart failure\n * Cirrhosis and/or liver failure\n * Nephrotic syndrome\n\nExclusion Criteria:\n\n* Patients with hypovolemic hyponatremia\n* Use of investigational drug, biologic, or device during the study'}, 'identificationModule': {'nctId': 'NCT01240668', 'acronym': 'HN Registry', 'briefTitle': 'Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka America Pharmaceutical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '156-10-292'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hyponatremia Patients', 'description': 'Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.13362, 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'state': 'Tennessee', 'country': 'United States', 'facility': 'Saint Thomas Hospital', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardiopulmonary Research Science & Technology Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Baptist Hospital Downtown', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Renal Associates, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research and Consulting Centter', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'CAMC Institute Inc.', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Evangelische Lungenklinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Johann-Wolfgang-Goethe-Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Registrat-Mapi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}