Endocrine Abstracts (2011) 26 P209

Rationale and design of a global hyponatraemia registry

J Verbalis1, A Greenburg2 & P Gross3

1Georgetown University, Washington, District of Columbia, USA; 2Duke University, Durham, North Corolina, USA; 3Medizin Klinik, University Medical Center, Dresden, Germany.

Background: Hyponatraemia (HN) is the most common electrolyte disorder of hospitalised patients with a frequency approximating 15%. HN is associated with multiple co-morbidities as well as increases in length of stay (LOS), rehospitalisation, cardiovascular events, and death. This novel HN registry represents the first large-scale international effort to document the impact of HN on clinically relevant outcomes.

Methods: The HN registry is an ongoing, global, multi-centre, prospective, observational study designed to collect data on hyponatraemic patients in the hospital setting. HN is defined as serum sodium [Na]≤130 mmol/l. Objectives of the registry are to: i) obtain demographic data on HN patients; ii) demonstrate comparative effectiveness of available HN treatments; and iii) define and compare resource utilization in the management of HN patients. Out of a total of 2500 patients world-wide, up to 1000 patients with HN secondary to SIADH will be enrolled throughout Europe.

Results: Primary end points are: i) change in [Na] from beginning to end of treatment or discharge and ii) LOS from the time of diagnosis. Secondary end points includes: i) time to a [Na] increase of ≥5 mmol/l or time to [Na]≥130 mmol/l; ii) effectiveness of individual therapies in correcting [Na]; and iii) effectiveness of individual therapies in achieving improvement in symptoms. Impact of HN on resource utilization will be measured by LOS and duration of intensive care unit stay.

Conclusion: The HN registry will add valuable information to the current literature on SIADH-related HN and will provide important insights into the efficacy of current and emerging treatment options for HN and their impact on clinically relevant outcomes.

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