Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 主要终点
- The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
研究概览
简要总结
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units.
In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.
详细描述
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. Currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials.
This study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. Therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with hypernatremia (serum sodium>145mEq/L).
排除标准
- •Age below 18 years
- •Pregnant, on dialysis
- •Unwilling to participate or without informed consent.
研究组 & 干预措施
Intravenous hypotonic solution
In this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (>180mg/dL).
If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily.
If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day.
干预措施: Hypotonic Solution (Drug)
Enteral water
This group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
干预措施: Water Purified (Drug)
结局指标
主要结局
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
时间窗: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
Correction of hypernatremia is \<145mEq/L serum sodium
次要结局
- volume overload(the first 5 days of the study)
- mortality(the first 5 days of the study)
- renal function(the first 5 days of the study)
- neurological alterations(the first 5 days of the study)
研究者
Jonathan Samuel Chavez Iñiguez
Head of nephrology Dr. Jonathan Samuel Chavez Iñiguez
Hospital Civil de Guadalajara