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临床试验/NCT04020926
NCT04020926终止不适用

Impact of Hyponatremia on Muscle Strength, Gait and Balance, and Cognitive Function: a Prospective Observational Study

Bürgerspital Solothurn1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

In this study patients with hyponatremia, defined as a serum sodium < 126 mmol/L on admission to the hospital will be tested for muscular power by use of a hand grip dynamometer, for cognitive function by use of the Montreal-Cognitive-Assessment and gait stability by use of the Tinetti test. The tests will be performed on admission as well es after correction of hyponatremia.

详细描述

The investigators broad objective is to examine in a prospective study whether an association exists between hyponatremia and psychomotor deficits. The specific aims are:

A.) To measure muscle strength by use of a dynamometer in patients presenting with moderate to severe hyponatremia (serum sodium ≤ 125 mmol/L) at the emergency department before and after correction of hyponatremia (serum sodium ≥ 135 mmol/L).

B.) To test for balance and gait disorders before and after correction of hyponatremia C.) To investigate whether presence of hyponatremia is associated with cognitive impairment that isreversible after correction of serum sodium.

The hypothesis is that hyponatremia is associated with reduced muscle strength, impaired balance, and cognitive impairment, and that the correction of the serum sodium will lead to an improvement of these parameters.

Design & Setting

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

  • age 18 years or above
  • serum sodium ≤ 125 mmol/L
  • informed consent.

排除标准

  • age < 18 years
  • not give or are not able to give informed consent
  • K+<3.5 mmol/l
  • K+>5.0 mmol/l)

结局指标

主要结局

Cognitive Function

时间窗: Correction of hyponatremia (up to 1 week).

C.) Change in results for the Montreal Cognitive Assessment (MOCA) test to assess mild cognitive impairment before and after correction of hyponatremia.

Muscle strength

时间窗: Correction of hyponatremia (up to 1 week).

A.) Change in muscle strength in kilogram before and after correction of hyponatremia.

Mobility assessment

时间窗: Correction of hyponatremia (up to 1 week).

B.) Change in results for the Tinetti performance-oriented mobility assessment (POMA) to evaluate static and dynamic balance abilities during and after correction of hyponatremia.

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

LINDNER Gregor

Director Dept. of Internal and Emergency Medicine

Bürgerspital Solothurn

研究点 (1)

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