Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Reduction Asthma score
研究概览
简要总结
Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 2-18 years of age at moment of inclusion
- •Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
- •Requiring administration of IV salbutamol
排除标准
- •Patient is outside of specified age range
- •Patient has already received a -loading dose- of IV salbutamol in the general hospital
- •Lower airway infection with consolidation on a chest X ray -Patient has Down's Syndrome
- •Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
- •Patient has a primary/secondary immunodeficiency
- •Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
研究组 & 干预措施
Salbutamol loading dose
Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
干预措施: Salbutamol (Drug)
Sodium Chloride 0.9%
10 ml of Sodium Chloride 0.9% in 10 minutes.
干预措施: Sodium Chloride 0.9% (Drug)
结局指标
主要结局
Reduction Asthma score
时间窗: First 24 hours after admission on the PICU
The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour after administration of loading dose in the intervention group compared to the placebo group. Based on expert opinion, we consider a reduction of 2 points to represent a clinically relevant improvement.
次要结局
- Use of/duration of non-invasive mechanical ventilation in days(Through study completion, an average 72 hours)
- DNA polymorphism of the ADRB2-receptor gene(Through study completion, an average 1 year)
- Total duration of IV salbutamol treatment in hours(Through study completion, an average 48 hours)
- Length of Stay on PICU in days(Through study completion, an average 72 hours)
- Use of co-medication(Through study completion, an average 72 hours)
- Cumulative dose of IV salbutamol(Through study completion, an average 48 hours)
- Maximum infusion rate of IV salbutamol in mcg/kg/min(Through study completion, an average 48 hours)
- Occurrence/frequency of side effects(Through study completion, an average 48 hours)
- Use of/duration of non-invasive/invasive mechanical ventilation in days(Through study completion, an average 72 hours)
研究者
Matthijs de Hoog
Principal Investigator
Erasmus Medical Center