Clinical trial NCT01240668: Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Euvolemic Hyponatremia
Hypervolemic Hyponatremia
Keywords: Hyponatremia
Euvolemia
Hypervolemia
Euvolemic
Hypervolemic
Lead sponsor: Otsuka America Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2010-11-15
Enrollment: 5028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
measure: Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.
timeFrame: Hospital Discharge
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
Other outcomes:
Locations:
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Inglewood
country: United States
facility: Chrishard Medical Group
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Denver
country: United States
facility: Portercare Adventist Health System
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Cardiovascular Center
state: Florida
city: Miami
country: United States
facility: Kidney & HTN Specialists of Miami
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Port Charlotte
country: United States
facility: Coastal Nephrology Associates Research
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Augusta
country: United States
facility: Joseph M Still Research Foundation, Inc
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Multi-Organ Transplant Center
state: Louisiana
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Mt Pleasant
country: United States
facility: Central Michigan Community Hospital
state: Michigan
city: Novi
country: United States
facility: Providence Park Hospital
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Heart Specialists
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Hosptial
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Livingston
country: United States
facility: Hypertenstion and Renal Group
state: New Jersey
city: Paterson
country: United States
facility: St Joseph's Regional Medical Center
state: New Jersey
city: Princeton Junction
country: United States
facility: Princeton Hypertension Nephrology Associates
state: New Jersey
city: Boston
country: United States
facility: Tufts New England Medical Center
state: New York
city: Bronx
country: United States
facility: Jack D. Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: Jamaica
country: United States
facility: The Jamaica Hospital Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center-Petrie Division
state: New York
city: New York
country: United States
facility: Center for Liver Disease and Transplantation
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: NYU
state: New York
city: Rochester
country: United States
facility: Rochester General
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Smithtown
country: United States
facility: St Catherine of Siena Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: Piedmont Respiratory Research
state: North Carolina
city: Canton
country: United States
facility: Mercy Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cinncinati
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Fairfield
country: United States
facility: Mercy Hospital Fairfield
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Network
state: Ohio
city: Kettering
country: United States
facility: Kidney Care Specialists
state: Ohio
city: Youngstown
country: United States
facility: St Elizabeth Health Center
state: Ohio
city: Bethlehem
country: United States
facility: NE Clinical Research Center
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Eprata
country: United States
facility: Heart Specialists of Lancaster PC
state: Pennsylvania
city: Mansfield
country: United States
facility: Laurel Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Center for Liver Disease
state: Pennsylvania
city: Orangeburg
country: United States
facility: SC Nephrology & Hypertension Ctr
state: South Carolina
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Cardiopulmonary Research Science & Technology Institute
state: Texas
city: San Antonio
country: United States
facility: Baptist Hospital Downtown
state: Texas
city: San Antonio
country: United States
facility: Renal Associates, PA
state: Texas
city: Fairfax
country: United States
facility: Clinical Research and Consulting Centter
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Charleston
country: United States
facility: CAMC Institute Inc.
state: West Virginia
city: Berlin
country: Germany
facility: Evangelische Lungenklinik
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe-Universität
city: Köln
country: Germany
facility: Universitätsklinik Köln
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
References: