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

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

  Show 82 Study Locations
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 July 20, 2014