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临床试验/NCT04561531
NCT04561531Unknown不适用

Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital

Rajavithi Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Plasma sodium and glasglow coma scale(GCS)

研究概览

简要总结

To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.

详细描述

Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions.

Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa<125mmol/L) in Rajavithi Hospital into two groups:

First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.

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
None

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

  • Patients in Rajavithi Hospital
  • Age from 18 years
  • Plasma Na < 125 mmol/l with glucose-corrected
  • Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)

排除标准

  • Systolic BP < 90 mmHg Or MAP< 70 mmHg
  • Pregnancy or Lactation
  • Congestive Heart Failure or Volume overload
  • Lung congestionfrom CXR
  • Chronic renal failure patients with edema
  • Cirrhosis patients with edema
  • Patients with coronary artery disease
  • Patients with brain injuries
  • Deny consent

结局指标

主要结局

Plasma sodium and glasglow coma scale(GCS)

时间窗: 6 hours

Change in plasma sodium and level of consciousness (GCS)

次要结局

  • Plasma sodium and glasglow coma scale(GCS)(24 and 48 hours)
  • overcorrection rate(24 and 48 hours)
  • mortality rate(in 30 days)
  • hospitality days(until discharge)
  • ODS rate(in 7 days)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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