Trial record 1 of 2 for:    HN registry
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Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia (HN Registry)

This study has been completed.
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01240668
First received: November 11, 2010
Last updated: May 13, 2015
Last verified: May 2015
  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

Resource links provided by NLM:


Further study details as provided by Otsuka America Pharmaceutical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 5028
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: June 2013 (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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240668

  Hide Study Locations
Locations
United States, California
North America Research Institute
Azusa, California, United States
Chrishard Medical Group
Inglewood, California, United States
UCLA
Los Angeles, California, United States
Regional Cardiology Associates
Sacramento, California, United States
United States, Colorado
Portercare Adventist Health System
Denver, Colorado, United States
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States
United States, Florida
Memorial Healthcare System
Hollywood, Florida, United States
Jacksonville Cardiovascular Center
Jacksonville, Florida, United States, 32216
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
United States, Georgia
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Joseph M Still Research Foundation, Inc
Augusta, Georgia, United States, 30909
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
United States, Kentucky
Research Integrity, LLC
Owensboro, Kentucky, United States
United States, Louisiana
Ochsner Multi-Organ Transplant Center
New Orleans, Louisiana, United States
United States, Michigan
Detroit Medical Center
Detroit, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Central Michigan Community Hospital
Mt 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
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States
United States, Missouri
Saint Louis University Hosptial
Saint Louis, Missouri, United States
United States, Nebraska
Creighton University
Omaha, Nebraska, United States
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
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
United States, New York
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
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
United States, North Carolina
Duke University
Durham, North Carolina, United States
Piedmont Respiratory Research
Greensboro, North Carolina, United States
United States, Ohio
Mercy Hospital
Canton, Ohio, United States
University of Cinncinati
Cincinnati, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic
Cleveland, Ohio, United States
Mercy Hospital Fairfield
Fairfield, Ohio, United States, 45104
Kettering Health Network
Kettering, Ohio, United States
Kidney Care Specialists
Kettering, Ohio, United States
St Elizabeth Health Center
Youngstown, Ohio, United States
United States, Pennsylvania
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
United States, South Carolina
SC Nephrology & Hypertension Ctr
Orangeburg, South Carolina, United States
United States, Tennessee
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Saint Thomas Hospital
Nashville, Tennessee, United States
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas, United States
Renal Associates, PA
San Antonio, Texas, United States
Baptist Hospital Downtown
San Antonio, Texas, United States, 78205
United States, Virginia
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
United States, West Virginia
CAMC Institute Inc.
Charleston, West Virginia, United States
Germany
Evangelische Lungenklinik
Berlin, Germany
Klinikum Chemnitz
Chemnitz, Germany
Klinikum der Johann-Wolfgang-Goethe-Universität
Frankfurt, Germany
Universitätsklinik Köln
Köln, Germany
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Royal Victoria Infirmary
Newcastle, United Kingdom
Sponsors and Collaborators
Otsuka America Pharmaceutical
Registrat-Mapi
  More Information

No publications provided

Responsible Party: Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier: NCT01240668     History of Changes
Other Study ID Numbers: 156-10-292
Study First Received: November 11, 2010
Last Updated: May 13, 2015
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
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on July 30, 2015