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临床试验/NCT01631929
NCT01631929终止不适用

Two Bag System vs. One Bag System for Hydration Patients With Diabetic Ketoacidosis

Hospital General de Niños Pedro de Elizalde2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
主要终点
Time to Achieve Patient Stabilization

研究概览

简要总结

This is a randomized controlled trial comparing the time needed to get the conditions to space hourly controls to controls every 4 hours, using the one bag system versus the two bags system, in the initial treatment of children with diabetic ketoacidosis. After fast infusion of isotonic saline solution (20 ml/kg) to prevent shock, the administration of maintenance fluids and insulin therapy is indicated. Hourly plasmatic levels of glucose controls could determine changes in glucose IV administration. On using the classic one bag system each change determine a bag change. Using the two bag system allows to deliver the patient the appropriate glucose infusion in less time.

详细描述

The treatment of children with diabetic ketoacidosis includes fast infusion of isotonic saline solution to prevent shock (20 ml/kg), and then the administration of maintenance fluids and insulin therapy according to hourly plasmatic glucose levels controls. Finally, after patients stabilization, controls becomes less frequents (each 4 hours).

During the stabilization period infusion of glucose is calculated hourly according to plasmatic glucose levels. These modifications in IV infusion can be very frequent, sometimes by the hour, requiring preparation of a new solution for hydration (in a new bag).

This procedure takes time, during which the patient continues receiving the previous IV infusion until the changes are effectively made. Therefore, usually changes are not strictly hourly, interfering with the adjustment of the organism to the above mentioned changes.

The 2 bag system consists in using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line. Using this system allows that changes needed in the administration of fluids and/or dextrose, may be easily and instantly managed by delivering different amounts from each bag to achieve the desired infusion rate without having to replace the bag.

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
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 1 to 18 years old
  • Diabetic ketoacidosis(plasmatic glucose > 250mg/dl, pH < 7.3, bicarbonate < 15mmol/L, ketonuria and glycosuria)

排除标准

  • Patients who already received insulin in the Emergency Department.
  • Patients who, because of their clinical condition, require admission to intensive care unit.

结局指标

主要结局

Time to Achieve Patient Stabilization

时间窗: Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)

Time needed to achieve patient stabilization defined by: * Plasmatic glucose \< 250 mg/dl * Blood pH \> 7.3 * Plasmatic bicarbonate \> 15 mmol/L

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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