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临床试验/NCT06498856
NCT06498856尚未招募不适用

Saline Infusion Test in Hyponatremia

University Hospital, Akershus0 个研究点目标入组 100 人开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Copeptin plasma levels

研究概览

简要总结

Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

详细描述

Hyponatremia (low plasma sodium concentration) is a common electrolyte disorder among hospitalized patients that can lead to complications such as gait instability, falls and mental changes. Both hyponatremia itself and overly rapid correction of hyponatremia may lead to brain damage.

There are several underlying causes of hyponatremia that require different treatment strategies. Specifically, hypovolemia is treated with fluid infusion while other common causes such as the syndrome of inappropriate diuresis (SIAD) and hypervolemic conditions need fluid restriction. In clinical practice, it can be challenging to identify the main cause of hyponatremia due to overlapping diagnosis and unreliable diagnostic tools, typically leading to a timely trial and error approach to therapy.

A saline infusion test (SIT) is often used to diagnose hypovolemic hyponatremia. To our knowledge, the test has never been validated, but relies on the rationale that the sodium concentration will increase more with saline infusion in hypovolemia than in other causes of hyponatremia. Typically, one liter of isotonic saline is infused intravenously and an arbitrarily set cut-off for sodium increase is used to indicate hypovolemia. As the response of sodium depends on several factors that affects the renal free water excretion capacity, this measure may not be the most accurate nor the most efficient. Another, more direct, approach could be to measure the change in biochemical markers of circulating volume in response to the volume expansion that comes with saline infusion. We will measure several different biomarkers before, during and after a standardized isotonic saline infusion in patients hospitalized with hyponatremia. Based on the results, we hope to develop a more precise tool for the differential diagnosis of hyponatremia.

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

入选标准

  • Plasma sodium 120-130 mmol/L
  • Effective osmolality (2 x plasma sodium + plasma glucose) < 275 milliosmol/L
  • Age > 18 years

排除标准

  • Intensive care unit (ICU) admission
  • Adequate sodium correction rate: > 4 mmol/L last 24 hours
  • Primary polydipsia: urine osmolality < 100 mOsm/L
  • Hypertonic saline therapy
  • Adrenal insufficiency
  • Severe heart failure: ejection fraction < 35 % or clinical suspicion of decompensated heart failure
  • Ascites grade 3 (marked abdominal distention and discomfort)
  • Chronic renal failure stage 4 or 5: estimated glomerular filtration rate < 30
  • Failure to submit informed consent

结局指标

主要结局

Copeptin plasma levels

时间窗: 240 minutes

Changes in copeptin levels in response to isotonic saline infusion

次要结局

未报告次要终点

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Winther, MD, PhD

Head of Endocrinology department

University Hospital, Akershus

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