Euvolemic Hyponatremia Clinical Trial
— HN RegistryOfficial 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
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.
| Status | Completed |
| Enrollment | 5028 |
| Est. completion date | August 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Evangelische Lungenklinik | Berlin | |
| Germany | Klinikum Chemnitz | Chemnitz | |
| Germany | Klinikum der Johann-Wolfgang-Goethe-Universität | Frankfurt | |
| Germany | Universitätsklinik Köln | Köln | |
| United Kingdom | Birmingham Heartlands Hospital | Birmingham | |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | Royal Victoria Infirmary | Newcastle | |
| United States | St. Joseph's Hospital of Atlanta | Atlanta | Georgia |
| United States | Joseph M Still Research Foundation, Inc | Augusta | Georgia |
| United States | North America Research Institute | Azusa | California |
| United States | NE Clinical Research Center | Bethlehem | Pennsylvania |
| United States | Tufts New England Medical Center | Boston | New York |
| United States | Jack D. Weiler Hospital | Bronx | New York |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Buffalo General Hospital | Buffalo | New York |
| United States | Mercy Hospital | Canton | Ohio |
| United States | CAMC Institute Inc. | Charleston | West Virginia |
| United States | Southeast Renal Research Institute | Chattanooga | Tennessee |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Cinncinati | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Metrohealth Medical Center | Cleveland | Ohio |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | Cardiopulmonary Research Science & Technology Institute | Dallas | Texas |
| United States | Portercare Adventist Health System | Denver | Colorado |
| United States | Detroit Medical Center | Detroit | Michigan |
| United States | Detroit Receiving Hospital | Detroit | Michigan |
| United States | Delaware County Memorial Hospital | Drexel Hill | Pennsylvania |
| United States | Duke University | Durham | North Carolina |
| United States | Heart Specialists of Lancaster PC | Eprata | Pennsylvania |
| United States | Clinical Research and Consulting Centter | Fairfax | Virginia |
| United States | Mercy Hospital Fairfield | Fairfield | Ohio |
| United States | Piedmont Respiratory Research | Greensboro | North Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Memorial Healthcare System | Hollywood | Florida |
| United States | Chrishard Medical Group | Inglewood | California |
| United States | Jacksonville Cardiovascular Center | Jacksonville | Florida |
| United States | The Jamaica Hospital Medical Center | Jamaica | New York |
| United States | Kettering Health Network | Kettering | Ohio |
| United States | Kidney Care Specialists | Kettering | Ohio |
| United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
| United States | Hypertenstion and Renal Group | Livingston | New Jersey |
| United States | UCLA | Los Angeles | California |
| United States | Laurel Health System | Mansfield | Pennsylvania |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Kidney & HTN Specialists of Miami | Miami | Florida |
| United States | Winthrop-University Hospital | Mineola | New York |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | Central Michigan Community Hospital | Mt Pleasant | Michigan |
| United States | Naples Community Hospital | Naples | Florida |
| United States | Saint Thomas Hospital | Nashville | Tennessee |
| United States | Ochsner Multi-Organ Transplant Center | New Orleans | Louisiana |
| 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 | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Providence Park Hospital | Novi | Michigan |
| United States | Creighton University | Omaha | Nebraska |
| United States | SC Nephrology & Hypertension Ctr | Orangeburg | South Carolina |
| United States | Florida Hospital | Orlando | Florida |
| United States | Research Integrity, LLC | Owensboro | Kentucky |
| United States | St Joseph's Regional Medical Center | Paterson | New Jersey |
| United States | Northern Michigan Hospital | Petoskey | Michigan |
| United States | UPMC Center for Liver Disease | Pittsburgh | Pennsylvania |
| United States | Coastal Nephrology Associates Research | Port Charlotte | Florida |
| United States | Princeton Hypertension Nephrology Associates | Princeton Junction | New Jersey |
| United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
| United States | Rochester General | Rochester | New York |
| United States | University of Rochester | Rochester | New York |
| United States | Regional Cardiology Associates | Sacramento | California |
| United States | Covenant Heart Specialists | Saginaw | Michigan |
| United States | Saint Louis University Hosptial | Saint Louis | Missouri |
| United States | Baptist Hospital Downtown | San Antonio | Texas |
| United States | Renal Associates, PA | San Antonio | Texas |
| United States | St Catherine of Siena Medical Center | Smithtown | New York |
| United States | Georgetown University Hospital | Washington | District of Columbia |
| United States | St Elizabeth Health Center | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Otsuka America Pharmaceutical | Registrat-Mapi |
United States, Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Primary | 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 | No | |
| Primary | Time to initiation of hyponatremia treatment | Hospital Discharge | No | |
| Secondary | Relative proportions of etiologies associated with hyponatremia | Hospital Discharge | No | |
| Secondary | Profile of investigations performed in diagnosing hyponatremia | Hospital Discharge | No | |
| Secondary | Therapies used in the management of hyponatremia | Hospital Discharge | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No | |
| Secondary | Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay | Hospital Discharge | No | |
| Secondary | Impact of hyponatremia on medically necessary length of stay | Hospital Discharge | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
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