Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in urine osmolality
研究概览
简要总结
To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia
详细描述
Achieving recommended treatment targets in management of hyponatremia is challenging: plasma sodium must be increased effectively but, at the same time, overcorrection has to be prevented. Yet, predictors of change of sodium over time have not been delineated properly. It was found, that evidence hinting to the fact that sodium baseline itself is crucial with respect to sodium evolution.
The goal of this study is to gather prospective data in order to precisely delineate the role of initial sodium levels by correlating those to plasma sodium evolution and electrolyte free water evolution. It is aimed to decipher patterns of sodium evolution with respect to anthropometric data, such as body composition analyses and blood pressure and markers of innate regulation mechanisms of body volume like aldosterone and renin. In addition, apart from these clinical aspects, a better appreciation of the physiological responses to hyponatremia treatment in terms of water and electrolyte balances is undoubtedly necessary to improve understanding of the body's mechanisms involved in osmotic homeostasis and cell volume control. Since studies to date also lack consideration of the intracellular department, the aim is to close that gap.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients ≥ 18 years
- •Hypotonic hyponatremia
- •glucose-corrected plasma sodium <130 mmol/l
- •serum osmolality <280 mosmol/kg or lack of signs of non-hypotonic hyponatremia
排除标准
- •Signs of extracellular volume expansion
- •Patients with liver cirrhosis and severe liver damage AST/ALT>3xULN, AP>6xULN, Bilirubin ≥ 3mg/dl
- •Patients with heart failure
- •Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl
- •Patients after organ transplantation
结局指标
主要结局
Changes in urine osmolality
时间窗: baseline, every day up to 30 days
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality
Changes in plasma osmolality
时间窗: baseline, every day up to 30 days
Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment
Changes in Plasma Sodium
时间窗: baseline, every day up to 30 days
Measurement of plasma sodium in blood samples
Changes in urine volume
时间窗: baseline, every day up to 30 days
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume
次要结局
- Changes in intracellular volume(baseline, every day up to 30 days)
- Changes in blood pressure(baseline, every day up to 30 days)
- Changes in copeptin levels(baseline, every day up to 30 days)
- Changes in renin levels(baseline, every day up to 30 days)
- Changes in aldosterone levels(baseline, every day up to 30 days)
- Changes in body weight(baseline, every day up to 30 days)
- Changes in extracellular volume(baseline, every day up to 30 days)
- Changes in cell size(baseline, every day up to 30 days)
- Changes in intracellular electrolyte levels(baseline, every day up to 30 days)
- Changes in total body water(baseline, every day up to 30 days)
研究者
Volker Burst
Prof. Dr.
University of Cologne