Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

NCT01240668 | Completed

• 1 other identifier: 156-10-292
• Study Type: observational
• Target: 5,028
• Locations: 3 countries
• Sites: 79

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.

Conditions

Euvolemic Hyponatremia; Hypervolemic Hyponatremia

Keywords

Hyponatremia; Euvolemia; Hypervolemia; Euvolemic; Hypervolemic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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.

  Hospital Discharge

• Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.

  Hospital Discharge

Study Arms (1)

Hyponatremia Patients

Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with hypovolemic hyponatremia
• Use of investigational drug, biologic, or device during the study

Sponsors & Collaborators

• Otsuka America Pharmaceutical: lead
• Registrat-Mapi: collaborator

Study Sites (79)

North America Research Institute

Azusa, California, United States

Location

Chrishard Medical Group

Inglewood, California, United States

Location

UCLA

Los Angeles, California, United States

Location

Regional Cardiology Associates

Sacramento, California, United States

Location

Portercare Adventist Health System

Denver, Colorado, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Location

Memorial Healthcare System

Hollywood, Florida, United States

Location

Jacksonville Cardiovascular Center

Jacksonville, Florida, 32216, United States

Location

Kidney & HTN Specialists of Miami

Miami, Florida, United States

Location

Naples Community Hospital

Naples, Florida, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

Coastal Nephrology Associates Research

Port Charlotte, Florida, United States

Location

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Location

Joseph M Still Research Foundation, Inc

Augusta, Georgia, 30909, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

Loyola University Medical Center

Maywood, Illinois, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, United States

Location

Ochsner Multi-Organ Transplant Center

New Orleans, Louisiana, United States

Location

Detroit Medical Center

Detroit, Michigan, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, United States

Location

Central Michigan Community Hospital

Mount Pleasant, Michigan, United States

Location

Providence Park Hospital

Novi, Michigan, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, United States

Location

Covenant Heart Specialists

Saginaw, Michigan, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Location

Saint Louis University Hosptial

St Louis, Missouri, United States

Location

Creighton University

Omaha, Nebraska, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89106, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

Hypertenstion and Renal Group

Livingston, New Jersey, United States

Location

St Joseph's Regional Medical Center

Paterson, New Jersey, United States

Location

Princeton Hypertension Nephrology Associates

Princeton Junction, New Jersey, United States

Location

Tufts New England Medical Center

Boston, New York, United States

Location

Buffalo General Hospital

Buffalo, New York, United States

Location

The Jamaica Hospital Medical Center

Jamaica, New York, United States

Location

Winthrop-University Hospital

Mineola, New York, United States

Location

Beth Israel Medical Center-Petrie Division

New York, New York, United States

Location

Center for Liver Disease and Transplantation

New York, New York, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

NYU

New York, New York, United States

Location

Rochester General

Rochester, New York, United States

Location

University of Rochester

Rochester, New York, United States

Location

St Catherine of Siena Medical Center

Smithtown, New York, United States

Location

Jack D. Weiler Hospital

The Bronx, New York, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Duke University

Durham, North Carolina, United States

Location

Piedmont Respiratory Research

Greensboro, North Carolina, United States

Location

Mercy Hospital

Canton, Ohio, United States

Location

University of Cinncinati

Cincinnati, Ohio, United States

Location

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Mercy Hospital Fairfield

Fairfield, Ohio, 45104, United States

Location

Kettering Health Network

Kettering, Ohio, United States

Location

Kidney Care Specialists

Kettering, Ohio, United States

Location

St Elizabeth Health Center

Youngstown, Ohio, United States

Location

NE Clinical Research Center

Bethlehem, Pennsylvania, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Location

Heart Specialists of Lancaster PC

Eprata, Pennsylvania, United States

Location

Laurel Health System

Mansfield, Pennsylvania, United States

Location

UPMC Center for Liver Disease

Pittsburgh, Pennsylvania, United States

Location

SC Nephrology & Hypertension Ctr

Orangeburg, South Carolina, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Location

Saint Thomas Hospital

Nashville, Tennessee, United States

Location

Baylor University Medical Center

Dallas, Texas, United States

Location

Cardiopulmonary Research Science & Technology Institute

Dallas, Texas, United States

Location

Baptist Hospital Downtown

San Antonio, Texas, 78205, United States

Location

Renal Associates, PA

San Antonio, Texas, United States

Location

Clinical Research and Consulting Centter

Fairfax, Virginia, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Location

CAMC Institute Inc.

Charleston, West Virginia, United States

Location

Evangelische Lungenklinik

Berlin, Germany

Location

Klinikum Chemnitz

Chemnitz, Germany

Location

Universitätsklinik Köln

Cologne, Germany

Location

Klinikum der Johann-Wolfgang-Goethe-Universität

Frankfurt, Germany

Location

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Hyponatremia; Edema

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

GB (3); DE (4); US (72)