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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Otsuka America Pharmaceutical.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Registrat-Mapi
Information provided by:
Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01240668
First received: November 11, 2010
Last updated: April 21, 2011
Last verified: November 2010
  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 ]

Estimated Enrollment: 2505
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (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 Recruiting
Azusa, California, United States
Contact: Jenny Nguyen       JNGUYEN@NARIRESEARCH.COM   
Principal Investigator: Aamir Jamal         
Chrishard Medical Group Recruiting
Inglewood, California, United States
Contact: Christopher Scott       CHRISHARDMEDICAL@GMAIL.COM   
Principal Investigator: Cranford Scott         
UCLA Recruiting
Los Angeles, California, United States
Contact: Mohamad Rashid       MRASHID@MEDNET.UCLA.EDU   
Principal Investigator: Anjay Rastogi         
Regional Cardiology Associates Recruiting
Sacramento, California, United States
Contact: Lori Favaro       LFAVARO@RCAMD.COM   
Principal Investigator: John Chin         
United States, Colorado
Portercare Adventist Health System Recruiting
Denver, Colorado, United States
Contact: David Bynum       DAVIDBYNUM@CENTURA.ORG   
Principal Investigator: Jeffrey Giullian         
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States
Contact: Lucy Kim       ILK3@GEORGETOWN.EDU   
Principal Investigator: Joseph Verbalis         
United States, Florida
Memorial Healthcare System Recruiting
Hollywood, Florida, United States
Contact: Becky Nembhard       RESEARCH@CCSFEMAIL.COM   
Principal Investigator: Kashmira Bhadha         
Jacksonville Cardiovascular Center Recruiting
Jacksonville, Florida, United States, 32216
Contact: Jewell Baker    904-493-6555    jbaker@jaxcardio.com   
Principal Investigator: Pulido         
Kidney & HTN Specialists of Miami Recruiting
Miami, Florida, United States
Contact: Jose Hidalgo       JANDRESHIDALGO@IPRSITES.COM   
Principal Investigator: Jorge Mordujovich         
Naples Community Hospital Recruiting
Naples, Florida, United States
Contact: Maggie Gurrier       MAGDALA@NAPLESNEPHROLOGY.COM   
Principal Investigator: Mark Russo         
Florida Hospital Recruiting
Orlando, Florida, United States
Contact: Pamela Ger       PAMELA.DONDELINGER@FLHOSP.ORG   
Principal Investigator: Harischandra Karunaratne         
Coastal Nephrology Associates Research Recruiting
Port Charlotte, Florida, United States
Contact: Rose Terza       RTERZA@EARTHLINK.NET   
Principal Investigator: Kianoosh Kaveh         
United States, Georgia
St. Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States
Contact: Sonya Mathewson       SMATHEWSON2@SJHA.ORG   
Principal Investigator: John O'Connell         
Joseph M Still Research Foundation, Inc Recruiting
Augusta, Georgia, United States, 30909
Contact: Charlie Hatcher    706-364-2966    CHARLIE.HATCHER@JMSBURNCENTERS.COM   
Principal Investigator: Friedman         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States
Contact: Casey Gashti       CASEY_GASHTI@RUSH.EDU   
Principal Investigator: Casey Gashti         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States
Contact: Yaser Haq       Y-HAQ@NORTHWESTERN.EDU   
Principal Investigator: Morris Goldman         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States
Contact: Theresa Krause       TKRAUSE@LUMC.EDU   
Principal Investigator: Anjana Pillai         
United States, Kentucky
Research Integrity, LLC Recruiting
Owensboro, Kentucky, United States
Contact: Timothy Hillard       thillard@drvora.com   
Principal Investigator: Kishor Vora         
United States, Louisiana
Ochsner Multi-Organ Transplant Center Recruiting
New Orleans, Louisiana, United States
Contact: Nicole Obleness       NOBLENESS@OCHSNER.ORG   
Principal Investigator: Hector Ventura         
United States, Michigan
Detroit Medical Center Recruiting
Detroit, Michigan, United States
Contact: Zora Injic       ZCVETKOV@DMC.ORG   
Principal Investigator: Jalal Ghali         
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States
Contact: Denise Rhoney       DRHONEY@WAYNE.EDU   
Principal Investigator: Denise Rhoney         
Central Michigan Community Hospital Recruiting
Mt Pleasant, Michigan, United States
Contact: Wynona Packard       WPACKARD@CMCH.ORG   
Principal Investigator: John McClure         
Providence Park Hospital Recruiting
Novi, Michigan, United States
Contact: Kathy Russell       KATHERINE.RUSSELL@STJOHN.ORG   
Principal Investigator: Peter McCullough         
Northern Michigan Hospital Recruiting
Petoskey, Michigan, United States
Contact: Daniel Gerard       DGERARD@NORTHERNHEALTH.ORG   
Principal Investigator: Daniel Gerard         
Covenant Heart Specialists Recruiting
Saginaw, Michigan, United States
Contact: Ann Ostrander       AOSTRANDER@CHS-MI.COM   
Principal Investigator: Mayar Jundi         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States
Contact: Barb Wicklund       BWICKLUND@MMRF.ORG   
Principal Investigator: Bradley Bart         
United States, Missouri
Saint Louis University Hosptial Recruiting
Saint Louis, Missouri, United States
Contact: Christine Uhles       CTAAFFE1@SLU.EDU   
Principal Investigator: Joshua Stolker         
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States
Contact: Mark Malesker       MALESKER@CREIGHTON.EDU   
Principal Investigator: Mark Malesker         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Bindu Khanna    702-877-1887      
Principal Investigator: Bindu Khanna         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States
Contact: Susan Mathus       SMATHUS@HUMED.COM   
Principal Investigator: Robert Berkowitz         
Hypertenstion and Renal Group Recruiting
Livingston, New Jersey, United States
Contact: James Pritsiolas       JPRITSIOLAS@GMAIL.COM   
Principal Investigator: James Pritsiolas         
St Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States
Contact: Bogdana Dikovytska       DIKOVYTB@SJHMC.ORG   
Principal Investigator: Chandra Chandran         
Princeton Hypertension Nephrology Associates Recruiting
Princeton Junction, New Jersey, United States
Contact: Mary Ann Mertz       MARYANNMERTZ@GMAIL.COM   
Principal Investigator: Michael Ruddy         
United States, New York
Tufts New England Medical Center Recruiting
Boston, New York, United States
Contact: Jennifer Mackey       JMACKEY@TUFTSMEDICALCENTER.ORG   
Principal Investigator: David Denofrio         
Jack D. Weiler Hospital Recruiting
Bronx, New York, United States
Contact: Muhammad Sardar       MSARDAR@MONTEFIORE.ORG   
Principal Investigator: Ronald Zolty         
Montefiore Medical Center Recruiting
Bronx, New York, United States
Contact: Manhal Olaywi       MOLAYWI@MONTEFIORE.ORG   
Principal Investigator: Paul Gaglio         
Maimonides Medical Center Recruiting
Brooklyn, New York, United States
Contact: Maureen McCarthy       MMCCARTHY@MAIMONIDESMED.ORG   
Principal Investigator: Norbert Moskovits         
Buffalo General Hospital Recruiting
Buffalo, New York, United States
Contact: Lin Feng       LFENG@KALEIDAHEALTH.ORG   
Principal Investigator: Oleh Pankewycz         
The Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States
Contact: Mahboob Ali       MALI@JHMC.ORG   
Principal Investigator: Robert Mendelson         
Winthrop-University Hospital Recruiting
Mineola, New York, United States
Contact: John Maesaka       jmaesaka@winthrop.org   
Principal Investigator: John Maesaka         
NYU Recruiting
New York, New York, United States
Contact: Tommy Hahambis       THOMAS.HAHAMBIS@NYUMC.ORG   
Principal Investigator: Samuel Sigal         
Beth Israel Medical Center-Petrie Division Recruiting
New York, New York, United States
Contact: Roberto Gonzalez       ROGONZALEZ@CHPNET.ORG   
Principal Investigator: Albert Min         
Center for Liver Disease and Transplantation Recruiting
New York, New York, United States
Contact: Jessica Stiles       JBS2117@COLUMBIA.EDU   
Principal Investigator: Eva Sotil         
Mount Sinai School of Medicine Recruiting
New York, New York, United States
Contact: Vijay Lapsia       VIJAY.LAPSIA@MSSM.EDU   
Principal Investigator: Vijay Lapsia         
Rochester General Recruiting
Rochester, New York, United States
Contact: Patty Noll       PATRICIA.NOLL@ROCHESTERGENERAL.ORG   
Principal Investigator: Richard Sterns         
University of Rochester Recruiting
Rochester, New York, United States
Contact: Kathleen Neubeck       KATHLEEN_NEUBECK@URMC.ROCHESTER.EDU   
Principal Investigator: Benedict Maliakkal         
St Catherine of Siena Medical Center Recruiting
Smithtown, New York, United States
Contact: Gabriel Leonte       GABRIEL.LEONTE@CHSLI.ORG   
Principal Investigator: Ekambaram Ilamathi         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States
Contact: Debra Schumm       DEBRA.SCHUMM@DUKE.EDU   
Principal Investigator: Arthur Greenberg         
Piedmont Respiratory Research Recruiting
Greensboro, North Carolina, United States
Contact: Arshena Overton       ARSHENA.OVERTON@MOSESCONE.COM   
Principal Investigator: Murali Ramaswamy         
United States, Ohio
Mercy Hospital Recruiting
Canton, Ohio, United States
Contact: Ann Polen       ANNPOLEN@SBCGLOBAL.NET   
Principal Investigator: Frederick Whittier         
University of Cinncinati Recruiting
Cincinnati, Ohio, United States
Contact: Heather Duncan       HEATHER.DUNCAN@UC.EDU   
Principal Investigator: Max Reif         
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Tani Martin    216-778-8447    TMARTIN@METROHEALTH.ORG   
Principal Investigator: Mark Dunlap         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States
Contact: Cynthia Wade       WILEYWC@CCF.ORG   
Principal Investigator: Robert O'Shea         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States
Contact: Jennifer Forney       FORNEYJ@CCF.ORG   
Principal Investigator: Nancy Albert         
Mercy Hospital Fairfield Recruiting
Fairfield, Ohio, United States, 45104
Contact: Michelle Clifford    513-603-8688    MDCLIFFORD@FUSE.NET   
Principal Investigator: Wagoner         
Kettering Health Network Recruiting
Kettering, Ohio, United States
Contact: Lynne Bradford       LYNNE.BRADFORD@KHNETWORK.ORG   
Principal Investigator: Ziwar Karabatak         
Kidney Care Specialists Recruiting
Kettering, Ohio, United States
Contact: Michele Jewell       MICHELE.JEWELL@KHNETWORK.ORG   
Principal Investigator: Ibrahim Ahmad         
St Elizabeth Health Center Recruiting
Youngstown, Ohio, United States
Contact: Maria Pusnik       MARIA_PUSNIK@HMIS.ORG   
Principal Investigator: Maria Pusnik         
United States, Pennsylvania
NE Clinical Research Center Recruiting
Bethlehem, Pennsylvania, United States
Contact: Alex Harrison       ZANDERLEE88@YAHOO.COM   
Principal Investigator: Nelson Kopyt         
Delaware County Memorial Hospital Recruiting
Drexel Hill, Pennsylvania, United States
Contact: Amit Kapoor       AKAP02@YAHOO.COM   
Principal Investigator: Amit Kapoor         
Heart Specialists of Lancaster PC Recruiting
Eprata, Pennsylvania, United States
Contact: Elise Hartranft       EGHARTRANFT@AOL.COM   
Principal Investigator: Elise Hartranft         
Laurel Health System Recruiting
Mansfield, Pennsylvania, United States
Contact: George Dy       GRDY@PTD.NET   
Principal Investigator: George Dy         
UPMC Center for Liver Disease Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Mary Beth Luce       lucem@upmc.edu   
Principal Investigator: Mordechai Rabinovitz         
United States, South Carolina
SC Nephrology & Hypertension Ctr Recruiting
Orangeburg, South Carolina, United States
Contact: Becky Brewington       BECKYBREW924@HOTMAIL.COM   
Principal Investigator: Moustafa Moustafa         
United States, Tennessee
Southeast Renal Research Institute Recruiting
Chattanooga, Tennessee, United States
Contact: Cindy Spurgeon       CINDYYANCY@NEPHASSOCIATES.COM   
Principal Investigator: James Tumlin         
Saint Thomas Hospital Recruiting
Nashville, Tennessee, United States
Contact: Danielle Buchanan       DANIELLE.BUCHANAN@BAPTISTHOSPITAL.COM   
Principal Investigator: Douglas Pearce         
United States, Texas
Cardiopulmonary Research Science & Technology Institute Recruiting
Dallas, Texas, United States
Contact: Tina Worley       TWORLEY@CRSTI.ORG   
Principal Investigator: Eric Eichhorn         
Baylor University Medical Center Recruiting
Dallas, Texas, United States
Contact: Michelle Acker       MICHELCO@BAYLORHEALTH.EDU   
Principal Investigator: Jacqueline O'Leary         
Baptist Hospital Downtown Recruiting
San Antonio, Texas, United States, 78205
Contact: Mary Ann Garza    210-212-7122      
Principal Investigator: Mizani         
Renal Associates, PA Recruiting
San Antonio, Texas, United States
Contact: Letti Hudson       LHUDSON@RAPARESEARCH.COM   
Principal Investigator: Pablo Pergola         
United States, Virginia
Clinical Research and Consulting Centter Recruiting
Fairfax, Virginia, United States
Contact: Maria Obied       MOBEID@CLINICALRESEARCHLLC.COM   
Principal Investigator: Renuka Sothinathan         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States
Contact: Marci Holladay       MJMEDEIR@SENTARA.COM   
Principal Investigator: Thomas McCune         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States
Contact: Kathleen Genther       KGENTHER@MCVH-VCU.EDU   
Principal Investigator: Gretchen Brophy         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States
Contact: Kathleen Genther       KGENTHER@MCVH-VCU.EDU   
Principal Investigator: Arun Sanyal         
United States, West Virginia
CAMC Institute Inc. Recruiting
Charleston, West Virginia, United States
Contact: Philip Scott Lavigne       PHILIPSCOTTLAVIGNE@CAMC.ORG   
Principal Investigator: Bernardo Reyes         
Germany
Evangelische Lungenklinik Recruiting
Berlin, Germany
Contact: Christian Grohe       sekr.pneumologie@elk-berlin.de   
Principal Investigator: Christian Grohe         
Klinikum Chemnitz Recruiting
Chemnitz, Germany
Contact: Uwe Lindner       u.lindner@skc.de   
Principal Investigator: Uwe Lindner         
Klinikum der Johann-Wolfgang-Goethe-Universität Recruiting
Frankfurt, Germany
Contact: Maria Sandler       MARIA.SANDLER@KGU.DE   
Principal Investigator: Joerg Bojunga         
Universitätsklinik Köln Recruiting
Köln, Germany
Contact: Volker Burst, Doctor       volker.burst@uk-koeln.de   
Principal Investigator: Volker Burst         
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom
Contact: Jahyadave Shakher       Jahyadave.shakher@heartofengland.nhs.uk   
Principal Investigator: Jahyadave Shakher         
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
Contact: Tej Purewal       TPUREWAL@NHS.NET   
Principal Investigator: Tej Purewal         
Royal Victoria Infirmary Recruiting
Newcastle, United Kingdom
Contact: Stephen Ball       Steve.Ball@nuth.nhs.uk   
Principal Investigator: Stephen Ball         
Sponsors and Collaborators
Otsuka America Pharmaceutical
Registrat-Mapi
  More Information

No publications provided

Responsible Party: Sonnie Kim, Otsuka America Pharmaceutical, Inc
ClinicalTrials.gov Identifier: NCT01240668     History of Changes
Other Study ID Numbers: 156-10-292
Study First Received: November 11, 2010
Last Updated: April 21, 2011
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
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014