Euvolemic HyponatremiaHN RegistryNCT01240668
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia
An observational study of Euvolemic Hyponatremia and Hypervolemic Hyponatremia, run by Otsuka America Pharmaceutical at 79 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Euvolemic Hyponatremia, Hypervolemic Hyponatremia
- How many people
- 5,028 participants
- Where
- 79 sitesin 3 countries
- Study dates
- Sep 2010to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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):
Show all 11Show fewer
- 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
Who cannot join
- Patients with hypovolemic hyponatremia
- Use of investigational drug, biologic, or device during the study
Trial locations and contacts
79 sites in 3 countries.
79 sites in 3 countries
United States72 sites
St. Joseph's Hospital of Atlanta
Atlanta, Georgia
Joseph M Still Research Foundation, Inc
Augusta, Georgia, 30909
North America Research Institute
Azusa, California
NE Clinical Research Center
Bethlehem, Pennsylvania
Tufts New England Medical Center
Boston, New York
Buffalo General Hospital
Buffalo, New York
Mercy Hospital
Canton, Ohio
CAMC Institute Inc.
Charleston, West Virginia
Southeast Renal Research Institute
Chattanooga, Tennessee
Northwestern Memorial Hospital
Chicago, Illinois
Rush University Medical Center
Chicago, Illinois
University of Cinncinati
Cincinnati, Ohio
Metrohealth Medical Center
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio
Baylor University Medical Center
Dallas, Texas
Cardiopulmonary Research Science & Technology Institute
Dallas, Texas
Portercare Adventist Health System
Denver, Colorado
Detroit Medical Center
Detroit, Michigan
Detroit Receiving Hospital
Detroit, Michigan
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania
Duke University
Durham, North Carolina
Heart Specialists of Lancaster PC
Eprata, Pennsylvania
Clinical Research and Consulting Centter
Fairfax, Virginia
Mercy Hospital Fairfield
Fairfield, Ohio, 45104
Piedmont Respiratory Research
Greensboro, North Carolina
Hackensack University Medical Center
Hackensack, New Jersey
Memorial Healthcare System
Hollywood, Florida
Chrishard Medical Group
Inglewood, California
Jacksonville Cardiovascular Center
Jacksonville, Florida, 32216
The Jamaica Hospital Medical Center
Jamaica, New York
Kettering Health Network
Kettering, Ohio
Kidney Care Specialists
Kettering, Ohio
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89106
Hypertenstion and Renal Group
Livingston, New Jersey
UCLA
Los Angeles, California
Laurel Health System
Mansfield, Pennsylvania
Loyola University Medical Center
Maywood, Illinois
Kidney & HTN Specialists of Miami
Miami, Florida
Winthrop-University Hospital
Mineola, New York
Hennepin County Medical Center
Minneapolis, Minnesota
Central Michigan Community Hospital
Mount Pleasant, Michigan
Naples Community Hospital
Naples, Florida
Saint Thomas Hospital
Nashville, Tennessee
Ochsner Multi-Organ Transplant Center
New Orleans, Louisiana
Beth Israel Medical Center-Petrie Division
New York, New York
Center for Liver Disease and Transplantation
New York, New York
Mount Sinai School of Medicine
New York, New York
NYU
New York, New York
Sentara Norfolk General Hospital
Norfolk, Virginia
Providence Park Hospital
Novi, Michigan
Creighton University
Omaha, Nebraska
SC Nephrology & Hypertension Ctr
Orangeburg, South Carolina
Florida Hospital
Orlando, Florida
Research Integrity, LLC
Owensboro, Kentucky
St Joseph's Regional Medical Center
Paterson, New Jersey
Northern Michigan Hospital
Petoskey, Michigan
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania
Coastal Nephrology Associates Research
Port Charlotte, Florida
Princeton Hypertension Nephrology Associates
Princeton Junction, New Jersey
Virginia Commonwealth University Medical Center
Richmond, Virginia
Rochester General
Rochester, New York
University of Rochester
Rochester, New York
Regional Cardiology Associates
Sacramento, California
Covenant Heart Specialists
Saginaw, Michigan
Baptist Hospital Downtown
San Antonio, Texas, 78205
Renal Associates, PA
San Antonio, Texas
St Catherine of Siena Medical Center
Smithtown, New York
Saint Louis University Hosptial
St Louis, Missouri
Jack D. Weiler Hospital
The Bronx, New York
Montefiore Medical Center
The Bronx, New York
Georgetown University Hospital
Washington D.C., District of Columbia
St Elizabeth Health Center
Youngstown, Ohio
Germany4 sites
Evangelische Lungenklinik
Berlin
Klinikum Chemnitz
Chemnitz
Universitätsklinik Köln
Cologne
Klinikum der Johann-Wolfgang-Goethe-Universität
Frankfurt
United Kingdom3 sites
Birmingham Heartlands Hospital
Birmingham
Royal Liverpool University Hospital
Liverpool
Royal Victoria Infirmary
Newcastle
About this study
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
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
- Medical subject headings
- Hyponatremia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyponatremia Patients | Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum sodium concentration from beginning of treatment period to the end of treatment period or discharge for a given hyponatremia treatment
Measured: 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
Measured: Hospital Discharge
Time to initiation of hyponatremia treatment
Measured: Hospital Discharge
Secondary outcomes (8)
Relative proportions of etiologies associated with hyponatremia
Measured: Hospital Discharge
Profile of investigations performed in diagnosing hyponatremia
Measured: Hospital Discharge
Therapies used in the management of hyponatremia
Measured: 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
Measured: 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
Measured: 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
Measured: Hospital Discharge
Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay
Measured: Hospital Discharge
Impact of hyponatremia on medically necessary length of stay
Measured: Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euvolemic HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka America Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240668
- Sponsor's protocol ID
- 156-10-292
- Acronym
- HN Registry
- Status last verified
- May 2015
- First submitted
- 11 Nov 2010
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01240668
- Acronym / sponsor ID
- HN Registry / 156-10-292
- Conditions
- Euvolemic Hyponatremia, Hypervolemic Hyponatremia
- Keywords
- Hyponatremia, Euvolemia, Hypervolemia, Euvolemic, Hypervolemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,028 participants (actual)
- Lead sponsor
- Otsuka America PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyponatremia Patients | – | –Euvolemic or hypervolemic hyponatremia with serum sodium ≤130 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Adults ≥18 years old who are hospitalized
- Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L
- For euvolemic hyponatremia:
- For hypervolemic hyponatremia (applies to USA sites only):
Key exclusion criteria (2 listed)
- Patients with hypovolemic hyponatremia
- Use of investigational drug, biologic, or device during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Time to initiation of hyponatremia treatment
Time frame: Hospital Discharge
8 secondary outcomes
Relative proportions of etiologies associated with hyponatremia
Time frame: Hospital Discharge
Profile of investigations performed in diagnosing hyponatremia
Time frame: Hospital Discharge
Therapies used in the management of hyponatremia
Time frame: Hospital Discharge
Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.
Time frame: Hospital Discharge
Effectiveness of individual therapies in correcting hyponatremia and time taken to achieve the correction.
Time frame: 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
Time frame: Hospital Discharge
Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay
Time frame: Hospital Discharge
Impact of hyponatremia on medically necessary length of stay
Time frame: Hospital Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
79 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Euvolemic Hyponatremia and Hypervolemic Hyponatremia, run by Otsuka America Pharmaceutical at 79 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.