Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ICU length of stay
研究概览
简要总结
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.
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
- Double
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
- •Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
- •Age between birth and 18 years old
排除标准
- •Pre-existing cardiac or pulmonary disease
- •Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
- •Hemodynamic or cardiovascular instability requiring inotropic support
- •The patient meets one of the criteria for withdrawal from the study due to patient safety concerns
结局指标
主要结局
ICU length of stay
次要结局
- To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
- To prospectively analyze the side effects of terbutaline
研究者
Christopher Carroll, MD
Associate Professor of Pediatrics
Connecticut Children's Medical Center