Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,278
- 试验地点
- 18
- 主要终点
- The primary outcome is the combined risk of death or rehospitalization within 30 days
研究概览
简要总结
Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. While treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. Accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge.
This is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. Yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality.
The aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to allocated treatment group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult hospitalised patients with hypotonic hyponatremia <130mmol/L
- •Hospitalization of at least 24 h after inclusion in the study
排除标准
- •severe symptomatic hyponatremia in need of intensive care treatment
- •non-hypotonic hyponatremia with plasma osmolality >280 milliosmol (mOsm)/kg
- •end of life care (palliative treatment)
结局指标
主要结局
The primary outcome is the combined risk of death or rehospitalization within 30 days
时间窗: 30 days
Rate of death or rehospitalization within 30 days
次要结局
- 30 days rehospitalization rate(30 days)
- 1 year mortality rate(1 year)
- number of adverse events(1 year)
- Rate of Plasma sodium normalization at discharge(up to 1 year)
- Change in Plasma sodium Levels(up to 1 year)
- 30 days mortality rate(30 days)
- 1 year rehospitalization rate(1 year)
- Time to rehospitalization(up to 1 year)
- Time to death(up to 1 year)
- length of hospital stay(up to 1 year)
- Recurrence of hyponatremia(1 year)
- Diagnostic accuracy of renin in the diagnosis of hyponatremia(1 day)
- Rate of falls(30 days)
- Rate of fractures(1 year)
- Severely symptomatic hyponatremia(up to 1 year)
- Severe adverse events(1 year)
- Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia(1 day)
- Sodium-overcorrection(up to 1 year)
- Diagnostic accuracy of copeptin in the diagnosis of hyponatremia(1 day)
- Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia(1 day)
- Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia(1 day)