A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to discharge
研究概览
简要总结
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
详细描述
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 years 0 days up to 20 years 364 days
- •Clinical diagnosis of asthma including both of the following:
- •Attending physician's primary working diagnosis is status asthmaticus
- •Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis
- •Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater
- •IV access or equivalent
- •Ability to understand and give informed consent/assent in English
排除标准
- •Prior enrollment in this study
- •Prior adverse reactions to magnesium
- •Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment
- •Admission for inpatient asthma care in preceding 2 weeks
- •Hemodynamic instability, impending respiratory failure or intubation
- •Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status
- •Significant renal or cardiac disease
- •Sickle cell anemia
- •Significant, active non-asthma pulmonary disease
研究组 & 干预措施
Magnesium
Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion.
干预措施: Magnesium Sulfate (Drug)
Control
Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to discharge
时间窗: Duration of hospital stay, typically 3-5 days
The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge.
次要结局
- Beta receptor haplotype(Once on enrollment)
研究者
Keith Cross
Assistant Professor of Pediatrics
University of Louisville