COMPARISON OF 0.45% AND 0.9% SALINE IN 5% DEXTROSE AS MAINTENANCE FLUIDS IN CHILDREN ADMITTED WITH ACUTE ILLNESS.

Department of Pediatrics1 个研究点分布在 1 个国家目标入组 162 人开始时间: 2019年11月23日最近更新: 2020年8月20日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Department of Pediatrics
入组人数: 162
试验地点: 1
主要终点: Proportion of subjects developing hyponatremia after receiving designated fluid for the specified time.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hospital acquired acute Hyponatremia is increasingly recognised as the cause of morbidity and mortality in children. It has been attributed primarily to the use of hypotonic intravenous fluids to maintain fluid an electrolyte balance. The use of isotonic fluid (0.9% Normal Saline with 5% Dextrose) is recommended in most circumstances. Hypotonic intravenous fluids containing less than or equal to 0.45% NaCL shouldnâ€™t be used to provide as a routine iv fluid maintenance requirement.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 3.00 Month(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•All the children more than 3 months and less than 12 years of age requiring fluid management.

排除标准

•a) Children with age less than 3 months of age and more than 12 years of age.
•b ) Children who have received more than 72 hours of intravenous fluid.
•d) Children with Renal Disease ( AKI), Cardiac disease ( CHF) or Pituitary dysfunction , Diabetes mellitus.
•e) Children with baseline sodium values, < 130 meq/dl and > 145 meq/dl.

结局指标

主要结局

Proportion of subjects developing hyponatremia after receiving designated fluid for the specified time.

时间窗: 72 hours

次要结局

1. Change in serum sodium levels from the baseline at 48,72 hours in whom iv fluids are continued.(2. Occurence of hyponatremia and hypernatremia.)

研究者

发起方

Department of Pediatrics

申办方类型

Government medical college

研究点 (1)

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