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NCT Number: NCT01240668

Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

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.

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Key information

Conditions

Euvolemic Hyponatremia Edema Hypervolemic Hyponatremia Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelische Lungenklinik, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. Time to initiation of hyponatremia treatment

    Time frame: Hospital Discharge

Secondary outcomes

  1. Relative proportions of etiologies associated with hyponatremia

    Time frame: Hospital Discharge

  2. Profile of investigations performed in diagnosing hyponatremia

    Time frame: Hospital Discharge

  3. Therapies used in the management of hyponatremia

    Time frame: Hospital Discharge

  4. 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

  5. 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

  6. 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

  7. Medically necessary length of hospital stay and duration of intensive care unit (ICU) stay

    Time frame: Hospital Discharge

  8. Impact of hyponatremia on medically necessary length of stay

    Time frame: Hospital Discharge

Sponsors and collaborators

Lead sponsor

Otsuka America Pharmaceutical

Industry

Collaborators

  • Registrat-Mapi

Registry information

Official study 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

Acronym: HN Registry

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2010
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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