跳至主要内容
临床试验/NCT05277584
NCT05277584已完成不适用

Prediction of Timely Evolution of Plasma Sodium in Treatment of Hyponatremia - Post Hoc-analysis of the Hyponatremia Registry

University of Cologne1 个研究点 分布在 1 个国家目标入组 3,460 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,460
试验地点
1
主要终点
Predictors of [Na+] slope due to therapy

研究概览

简要总结

The aim of this study is to further analyse the dataset of the Hyponatremia Registry, a multicenter, prospective, observational study conducted between September 2020 and February 2013 in the United States of America and the European Union. The primary interest was to provide evidence to investigators' hypothesis that baseline sodium levels are a predominant factor determining the rapidity of sodium increase irrespective of the given treatment. Further investigators aimed to identify other independent predictors of the increase of plasma sodium upon treatment.

详细描述

Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. Overly rapid sodium increase is associated with increased risk for osmotic demyelination. Smaller analyses have suggested that the slope of the sodium increment is higher with lower baseline sodium levels but this has not been confirmed in large datasets. Investigators have recently published the results of analysis on patients from the Otsuka HN-Registry on thiazide-induced hyponatremia (cooperation with Otsuka). In that dataset was founded the same association and there had been hints that this relationship holds true for all kinds of treatment including no treatment at all.

Investigators took the datasets of those patients presenting with Hyponatremia that could be classified into one etiology group by the treating physician for further analysis. Patients with euvolemic, hypervolemic, hypovolemic or thiazide-associated HN were included in investigators' analysis. Furthermore investigators only considered those cases in which the patient record provided at least one documented plasma [Na+] within <25 hours after the first plasma [Na+] ≤130mEq/L had been measured.

All variables collected in the HN registry were included in the data base. All available information on ingested or administered solutes was recorded. Linear mixed effects models were applied to conduct multivariable repeated measures analyses.

Following questions are to be answered in this study

  1. Is the baseline sodium level a predominant factor determining the rapidity of sodium increase?
  2. Ist he rapidity of sodium increase correlated to the given treatment?
  3. Can other predominant factors of slope of sodium increase be determined?

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hypotonic hyponatremia <130 mmol/l enrolled in the Hyponatremia Registry and classified as Euvolemic Hyponatremia, Hypervolemic Hyponatremia, Hypovolemic Hyponatremia or Thiazide associated Hyponatremia-Group

排除标准

  • Patients, who could not be assigned to one etiology group

结局指标

主要结局

Predictors of [Na+] slope due to therapy

时间窗: Enrollment

Assessing Evolution of plasma sodium within the first 24 hours after commencement of therapy to determine predictors for velocity of \[Na+\] increase.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Volker Burst

Prof. MD

University of Cologne

研究点 (1)

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