Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia (HN Registry)

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.

Study Overview

• Status: Completed
• Conditions: Euvolemic Hyponatremia; Hypervolemic Hyponatremia

• Study Type: Observational
• Enrollment (Actual): 5028

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Evangelische Lungenklinik
  • Chemnitz, Germany
    • Klinikum Chemnitz
  • Frankfurt, Germany
    • Klinikum der Johann-Wolfgang-Goethe-Universität
  • Köln, Germany
    • Universitätsklinik Köln
• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Heartlands Hospital
  • Liverpool, United Kingdom
    • Royal Liverpool University Hospital
  • Newcastle, United Kingdom
    • Royal Victoria Infirmary
• United States
  • California
    • Azusa, California, United States
      • North America Research Institute
    • Inglewood, California, United States
      • Chrishard Medical Group
    • Los Angeles, California, United States
      • UCLA
    • Sacramento, California, United States
      • Regional Cardiology Associates
  • Colorado
    • Denver, Colorado, United States
      • Portercare Adventist Health System
  • District of Columbia
    • Washington, District of Columbia, United States
      • Georgetown University Hospital
  • Florida
    • Hollywood, Florida, United States
      • Memorial Healthcare System
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Cardiovascular Center
    • Miami, Florida, United States
      • Kidney & HTN Specialists of Miami
    • Naples, Florida, United States
      • Naples Community Hospital
    • Orlando, Florida, United States
      • Florida Hospital
    • Port Charlotte, Florida, United States
      • Coastal Nephrology Associates Research
  • Georgia
    • Atlanta, Georgia, United States
      • St. Joseph's Hospital of Atlanta
    • Augusta, Georgia, United States, 30909
      • Joseph M Still Research Foundation, Inc
  • Illinois
    • Chicago, Illinois, United States
      • Rush University Medical Center
    • Chicago, Illinois, United States
      • Northwestern Memorial Hospital
    • Maywood, Illinois, United States
      • Loyola University Medical Center
  • Kentucky
    • Owensboro, Kentucky, United States
      • Research Integrity, LLC
  • Louisiana
    • New Orleans, Louisiana, United States
      • Ochsner Multi-Organ Transplant Center
  • Michigan
    • Detroit, Michigan, United States
      • Detroit Medical Center
    • Detroit, Michigan, United States
      • Detroit Receiving Hospital
    • Mt Pleasant, Michigan, United States
      • Central Michigan Community Hospital
    • Novi, Michigan, United States
      • Providence Park Hospital
    • Petoskey, Michigan, United States
      • Northern Michigan Hospital
    • Saginaw, Michigan, United States
      • Covenant Heart Specialists
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Hennepin County Medical Center
  • Missouri
    • Saint Louis, Missouri, United States
      • Saint Louis University Hosptial
  • Nebraska
    • Omaha, Nebraska, United States
      • Creighton University
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • University Medical Center of Southern Nevada
  • New Jersey
    • Hackensack, New Jersey, United States
      • Hackensack University Medical Center
    • Livingston, New Jersey, United States
      • Hypertenstion and Renal Group
    • Paterson, New Jersey, United States
      • St Joseph's Regional Medical Center
    • Princeton Junction, New Jersey, United States
      • Princeton Hypertension Nephrology Associates
  • New York
    • Boston, New York, United States
      • Tufts New England Medical Center
    • Bronx, New York, United States
      • Montefiore Medical Center
    • Bronx, New York, United States
      • Jack D. Weiler Hospital
    • Buffalo, New York, United States
      • Buffalo General Hospital
    • Jamaica, New York, United States
      • The Jamaica Hospital Medical Center
    • Mineola, New York, United States
      • Winthrop-University Hospital
    • New York, New York, United States
      • Mount Sinai School of Medicine
    • New York, 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
      • NYU
    • Rochester, New York, United States
      • University of Rochester
    • Rochester, New York, United States
      • Rochester General
    • Smithtown, New York, United States
      • St Catherine of Siena Medical Center
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University
    • Greensboro, North Carolina, United States
      • Piedmont Respiratory Research
  • Ohio
    • Canton, Ohio, United States
      • Mercy Hospital
    • Cincinnati, Ohio, United States
      • University of Cinncinati
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States
      • Cleveland Clinic
    • Fairfield, Ohio, United States, 45104
      • Mercy Hospital Fairfield
    • Kettering, Ohio, United States
      • Kettering Health Network
    • Kettering, Ohio, United States
      • Kidney Care Specialists
    • Youngstown, Ohio, United States
      • St Elizabeth Health Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States
      • NE Clinical Research Center
    • Drexel Hill, Pennsylvania, United States
      • Delaware County Memorial Hospital
    • Eprata, Pennsylvania, United States
      • Heart Specialists of Lancaster PC
    • Mansfield, Pennsylvania, United States
      • Laurel Health System
    • Pittsburgh, Pennsylvania, United States
      • UPMC Center for Liver Disease
  • South Carolina
    • Orangeburg, South Carolina, United States
      • SC Nephrology & Hypertension Ctr
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Southeast Renal Research Institute
    • Nashville, Tennessee, United States
      • Saint Thomas Hospital
  • Texas
    • Dallas, Texas, United States
      • Baylor University Medical Center
    • Dallas, Texas, United States
      • Cardiopulmonary Research Science & Technology Institute
    • San Antonio, Texas, United States, 78205
      • Baptist Hospital Downtown
    • San Antonio, Texas, United States
      • Renal Associates, PA
  • Virginia
    • Fairfax, Virginia, United States
      • Clinical Research and Consulting Centter
    • Norfolk, Virginia, United States
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States
      • Virginia Commonwealth University Medical Center
  • West Virginia
    • Charleston, West Virginia, United States
      • CAMC Institute Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hyponatremia Patients; Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative proportions of etiologies associated with hyponatremia		Hospital Discharge
Profile of investigations performed in diagnosing hyponatremia		Hospital Discharge
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: serum sodium >130; serum sodium ≥135 mmol/L; increase of serum sodium ≥5 mmol/L	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

Collaborators and Investigators

• Sponsor: Otsuka America Pharmaceutical
• Collaborators: Registrat-Mapi

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 11, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Hyponatremia; Euvolemia; Hypervolemia; Euvolemic; Hypervolemic
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 156-10-292