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| Name | Class |
|---|---|
| Registrat-Mapi | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyponatremia Patients | Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative proportions of etiologies associated with hyponatremia | Hospital Discharge | |
| Profile of investigations performed in diagnosing hyponatremia | Hospital Discharge | |
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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:
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:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North America Research Institute | Azusa | California | United States | |||
| Chrishard Medical Group |
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| 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:
| 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 |
| Inglewood |
| California |
| United States |
| UCLA | Los Angeles | California | United States |
| Regional Cardiology Associates | Sacramento | California | United States |
| Portercare Adventist Health System | Denver | Colorado | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | United States |
| Memorial Healthcare System | Hollywood | Florida | United States |
| Jacksonville Cardiovascular Center | Jacksonville | Florida | 32216 | United States |
| Kidney & HTN Specialists of Miami | Miami | Florida | United States |
| Naples Community Hospital | Naples | Florida | United States |
| Florida Hospital | Orlando | Florida | United States |
| Coastal Nephrology Associates Research | Port Charlotte | Florida | United States |
| St. Joseph's Hospital of Atlanta | Atlanta | Georgia | United States |
| Joseph M Still Research Foundation, Inc | Augusta | Georgia | 30909 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | United States |
| Rush University Medical Center | Chicago | Illinois | United States |
| Loyola University Medical Center | Maywood | Illinois | United States |
| Research Integrity, LLC | Owensboro | Kentucky | United States |
| Ochsner Multi-Organ Transplant Center | New Orleans | Louisiana | United States |
| Detroit Medical Center | Detroit | Michigan | United States |
| Detroit Receiving Hospital | Detroit | Michigan | United States |
| Central Michigan Community Hospital | Mount Pleasant | Michigan | United States |
| Providence Park Hospital | Novi | Michigan | United States |
| Northern Michigan Hospital | Petoskey | Michigan | United States |
| Covenant Heart Specialists | Saginaw | Michigan | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | United States |
| Saint Louis University Hosptial | St Louis | Missouri | United States |
| Creighton University | Omaha | Nebraska | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89106 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | United States |
| Hypertenstion and Renal Group | Livingston | New Jersey | United States |
| St Joseph's Regional Medical Center | Paterson | New Jersey | United States |
| Princeton Hypertension Nephrology Associates | Princeton Junction | New Jersey | United States |
| Tufts New England Medical Center | Boston | New York | United States |
| Buffalo General Hospital | Buffalo | New York | United States |
| The Jamaica Hospital Medical Center | Jamaica | New York | United States |
| Winthrop-University Hospital | Mineola | New York | United States |
| Beth Israel Medical Center-Petrie Division | New York | New York | United States |
| Center for Liver Disease and Transplantation | New York | New York | United States |
| Mount Sinai School of Medicine | New York | New York | United States |
| NYU | New York | New York | United States |
| Rochester General | Rochester | New York | United States |
| University of Rochester | Rochester | New York | United States |
| St Catherine of Siena Medical Center | Smithtown | New York | United States |
| Jack D. Weiler Hospital | The Bronx | New York | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| Duke University | Durham | North Carolina | United States |
| Piedmont Respiratory Research | Greensboro | North Carolina | United States |
| Mercy Hospital | Canton | Ohio | United States |
| University of Cinncinati | Cincinnati | Ohio | United States |
| Metrohealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Cleveland Clinic | Cleveland | Ohio | United States |
| Mercy Hospital Fairfield | Fairfield | Ohio | 45104 | United States |
| Kettering Health Network | Kettering | Ohio | United States |
| Kidney Care Specialists | Kettering | Ohio | United States |
| St Elizabeth Health Center | Youngstown | Ohio | United States |
| NE Clinical Research Center | Bethlehem | Pennsylvania | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | United States |
| Heart Specialists of Lancaster PC | Eprata | Pennsylvania | United States |
| Laurel Health System | Mansfield | Pennsylvania | United States |
| UPMC Center for Liver Disease | Pittsburgh | Pennsylvania | United States |
| SC Nephrology & Hypertension Ctr | Orangeburg | South Carolina | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | United States |
| Saint Thomas Hospital | Nashville | Tennessee | United States |
| Baylor University Medical Center | Dallas | Texas | United States |
| Cardiopulmonary Research Science & Technology Institute | Dallas | Texas | United States |
| Baptist Hospital Downtown | San Antonio | Texas | 78205 | United States |
| Renal Associates, PA | San Antonio | Texas | United States |
| Clinical Research and Consulting Centter | Fairfax | Virginia | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | United States |
| CAMC Institute Inc. | Charleston | West Virginia | United States |
| Evangelische Lungenklinik | Berlin | Germany |
| Klinikum Chemnitz | Chemnitz | Germany |
| Universitätsklinik Köln | Cologne | Germany |
| Klinikum der Johann-Wolfgang-Goethe-Universität | Frankfurt | Germany |
| Birmingham Heartlands Hospital | Birmingham | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | United Kingdom |
| Royal Victoria Infirmary | Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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