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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240668
First Posted: November 15, 2010
Last Update Posted: May 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Registrat-Mapi
Information provided by (Responsible Party):
Otsuka America Pharmaceutical
  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

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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 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 ]

    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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240668


  Show 79 Study Locations
Sponsors and Collaborators
Otsuka America Pharmaceutical
Registrat-Mapi
  More Information

Responsible Party: Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier: NCT01240668     History of Changes
Other Study ID Numbers: 156-10-292
First Submitted: November 11, 2010
First Posted: November 15, 2010
Last Update Posted: May 15, 2015
Last Verified: May 2015

Keywords provided by Otsuka America Pharmaceutical:
Hyponatremia
Euvolemia
Hypervolemia
Euvolemic
Hypervolemic

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases