A Phase I, Single Center, Placebo-Controlled, Blinded Pilot Study of Ipratropium Bromide in Children Admitted to the Intensive Care Unit With Status Asthmaticus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to q2 Albuterol
研究概览
简要总结
This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.
详细描述
Status asthmaticus is an acute exacerbation of asthma that often requires treatment in a pediatric intensive care unit (PICU). Standard therapies for status asthmaticus include corticosteroids and bronchodilators, typically albuterol. Ipratropium bromide is also a bronchodilator, but has a different mechanism of action than albuterol. The addition of Ipraropium to children in the Emergency Room with severe asthma exacerbations improves outcomes, so many PICU doctors treat patients with status asthmaticus with Ipratropium. However, two studies of children hospitalized in the general wards of the hospital (not the PICU) show that the addition of Ipratropium to standard care does not effect clinical outcomes. This study is a first step towards determining in Ipratropium is helpful in PICU patients (like it is in ER patients) or if it not helpful (like it is in general ward patients).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the PICU
- •Treatment with continuous albuterol via the Asthma Carepath
- •Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
- •Treatment with systemic corticosteroids by the clinical team
排除标准
- •First episode of wheezing that prompted treatment with bronchodilators by medical personnel
- •Prior enrollment in this study
- •Patients with chronic lung disease requiring routine home oxygen use
- •Allergy to inhaled ipratropium or inhaled saline
- •Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])
- •Pregnancy
- •Tracheostomy
- •Age < 2 years
- •Age > 17 years
- •Patient with pulmonary hypertension requiring daily therapy
- •Patient with cyanotic congenital heart disease
- •Cystic fibrosis
研究组 & 干预措施
Treatment
Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
干预措施: Ipratropium (Drug)
Treatment
Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
干预措施: Albuterol (Drug)
Placebo
Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days
干预措施: corticosteroids (Drug)
Treatment
Inhaled ipratropium bromide 250mcg given via nebulization every 6 hours for up to 5 days
干预措施: corticosteroids (Drug)
Placebo
Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days
干预措施: 0.9% Sodium Chloride (Drug)
Placebo
Inhaled normal saline 1.25mL given via nebulization every 6 hours for up to 5 days
干预措施: Albuterol (Drug)
结局指标
主要结局
Time to q2 Albuterol
时间窗: typically 12-48 hours
In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albuterol.
次要结局
- Hospital LOS (length of stay)(This outcome is assessed continually over the course of the study, typically 48-120 hours)
- PICU LOS (length of stay)(This outcome is assessed continually over the course of the study, typically 24-72 hours)
研究者
Steven Shein
Attending Physician
University Hospitals Cleveland Medical Center