Design of a prospective, multinational registry to evaluate patients hospitalized with hyponatremia: the HN Registry

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
P. Hauptman, A. Greenberg, J. Verbalis, A. Amin, S. Sigal, J. Chiong, S. Chase, J. Dasta
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引用次数: 10

Abstract

Background: Hyponatremia is a prevalent condition in patients hospitalized across a broad range of conditions, including heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Whether present on admission or developing during hospitalization, hyponatremia has been associated with increased mortality, longer hospital stays, and higher costs. Little is known, however, about its management and outcomes outside of clinical trial settings. Methods: The Hyponatremia Registry (HN Registry) is a prospective, observational, multicenter, multinational study of patients hospitalized with either hypervolemic hyponatremia (cirrhosis and heart failure) in the United States or euvolemic hyponatremia (SIADH) in both the United States and Europe. Study enrollment began in September 2010 at community, tertiary, and academic medical centers. Overall, the HN Registry is expected to enroll . 5,000 patients with hyponatremia, at . 280 sites. Data will be used to characterize demographic and clinical characteristics of patients hospitalized with hyponatremia, evaluate the comparative effectiveness of available treatment modalities, and document and compare length of hospital stay as a reflection of resource use associated with hospital management. Discussion: Despite better understanding of the clinical consequences, economic impact, and prognostic significance of euvolemic and hypervolemic hyponatremia, there remains a need to evaluate current “real-world” management. The HN Registry is designed to provide contemporary data on in-hospital evaluation, management, and length of stay in a large cohort of adult patients with hyponatremia. The HN Registry generated several design and analytical challenges that required unique approaches to facilitate collection of the most clinically relevant data.
设计一项前瞻性、多国登记来评估住院低钠血症患者:HN登记
背景:低钠血症是住院患者的一种常见疾病,包括心力衰竭、肝硬化和抗利尿激素(SIADH)分泌不当综合征。无论是入院时出现还是住院期间出现,低钠血症都与死亡率增加、住院时间延长和费用增加有关。然而,在临床试验设置之外,对其管理和结果知之甚少。方法:低钠血症登记(HN Registry)是一项前瞻性、观察性、多中心、多国研究,研究对象是美国的高血容量性低钠血症(肝硬化和心力衰竭)或美国和欧洲的低血容量性低钠血症(SIADH)住院患者。2010年9月开始在社区、高等教育和学术医疗中心进行研究登记。总体而言,预计HN注册中心将注册。5000例低钠血症患者。280网站。数据将用于描述低钠血症住院患者的人口学和临床特征,评估现有治疗方式的相对有效性,并记录和比较住院时间,以反映与医院管理相关的资源使用情况。讨论:尽管对低血容量血症和高血容量性低钠血症的临床后果、经济影响和预后意义有了更好的了解,但仍有必要评估当前的“现实世界”管理。HN登记处旨在提供大量低钠血症成年患者的住院评估、管理和住院时间的当代数据。HN Registry产生了一些设计和分析方面的挑战,需要独特的方法来促进最临床相关数据的收集。
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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