NCT00179127已完成不适用
Early Use of Insulin Glargine in Diabetic Ketoacidosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time of Acidosis Correction
研究概览
简要总结
The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.
The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
- •Established history of insulin dependent diabetes
- •Chief c/o hyperglycemia or vomiting
- •Venous pH < 7.24
- •Serum Bicarbonate < 18
- •Blood glucose > 150
- •Urinary Ketones
排除标准
- •Age < 6y.o.
- •New onset diabetes
- •Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
- •Venous pH > 7.24
- •Serum Bicarbonate > 18
- •Pregnancy
- •Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
研究组 & 干预措施
Glargine
Experimental
0.3u/kg of glargine, subcutaneously, once
干预措施: glargine (Drug)
Placebo
Placebo Comparator
0.3u/kg of saline, subcutaneously, once
干预措施: saline (Drug)
结局指标
主要结局
Time of Acidosis Correction
时间窗: Minutes
Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
次要结局
- Time on Insulin Drip(Minutes)
- Total Hospital Stay(Days)
研究者
研究点 (1)
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