Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
研究概览
简要总结
The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.
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
- 是
入选标准
- •age 18 or older
- •venous pH < 7.3 or arterial < 7.35
- •at least 2 of the following 3:
- •serum HCO3 < 18/anion gap > 16
- •serum glucose > 300 mg/dl
- •serum acetone positive
排除标准
- •less than age 18
研究组 & 干预措施
Subcutaneous Insulin
Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours
干预措施: Insulin (Aspart Insulin [Novolog], Regular Insulin) (Drug)
IV Regular Insulin
Intravenous Regular Insulin 0.1 units/kg/hour
干预措施: Insulin (Aspart Insulin [Novolog], Regular Insulin) (Drug)
Intravenous Novolog Insulin
Intravenous Novolog Insulin 0.1 units/kg/hour
干预措施: Insulin (Aspart Insulin [Novolog], Regular Insulin) (Drug)
结局指标
主要结局
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
时间窗: q 2 hours
Hours to achieve blood glucose less than 200mg/dl
时间窗: q 1 hour
次要结局
未报告次要终点
研究者
David Baldwin
MD
Rush University Medical Center