Clinical Significance of Hyponatremia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Prevalence of ODS in hyponatremia patients
研究概览
简要总结
Study Objectives and Hypothesis
To determine the incidence of hyponatremia at TYKS and the factors associated with it.
To assess how rapidly hyponatremia was corrected and how the rate of correction affected patient prognosis.
To evaluate treatment modalities and their impact on patient prognosis, length of hospital stay, and their appropriateness in comparison with national and international treatment guidelines.
To determine the incidence of osmotic demyelination at TYKS and the factors associated with it.
To assess other complications and their clinical significance.
To evaluate the impact of hyponatremia on various endpoints, such as mortality, length of hospital stay, seizures, confusion, and similar outcomes.
详细描述
Clinical Significance of Hyponatremia (Study Protocol)
Investigators: Tyko Hellsten, Anssi Mustonen, Ilpo Nuotio
Background of the Study General Background
Hyponatremia is a common electrolyte disorder occurring in approximately 15-30% of hospitalized patients (3,4). Most cases are mild and minimally symptomatic. The most clinically significant cases are rapidly developing severe hyponatremia, which may cause neurological emergencies and death, and chronic severe hyponatremia, in which overly rapid correction may lead to permanent neurological injury and, in the most severe cases, death (3,4). Hyponatremia is not an independent disease but a consequence of underlying illnesses, adverse drug effects, inappropriate fluid therapy, or, rarely, lifestyle-related factors.
Hyponatremia is classified as mild when serum sodium is 130-134 (-138) mmol/L. Although mild hyponatremia has been associated with increased hospital visits, prolonged hospital stays, sarcopenia, falls, fractures, and increased mortality, it is not typically an active target of treatment, and there are no reports on the effectiveness of its treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Two sodium measurements in Tyks laboratories between 12-36 hours.
排除标准
- 未提供
结局指标
主要结局
Prevalence of ODS in hyponatremia patients
时间窗: From enrollment to the end of the treamtent period. Usually 2-21 days.
The primary variable is dichotomous. It is defined based on radiologists' reports and confirmed by an expert panel.
Osmotic demyelination syndrome
时间窗: During the study period 1.1.2010-31.12.2020 wiht recorded sodium values.
Dichotomic 0/1, outcome defined from radiology reports.
次要结局
- Epidemiology and correction rates of hyponatremia(During any 24-hour period during the treatment period.)
- Prognosis linked to severe or moderate hyponatremia(1, 6 and 12 months after enrollment)