Clinical trial NCT03493503: Status Asthmaticus on the PICU; Intravenous Salbutamol
Official title: Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Childhood Asthma With Status Asthmaticus
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reduction Asthma score
timeFrame: First 24 hours after admission on the PICU
Secondary outcomes:
measure: Cumulative dose of IV salbutamol
timeFrame: Through study completion, an average 48 hours
measure: Maximum infusion rate of IV salbutamol in mcg/kg/min
timeFrame: Through study completion, an average 48 hours
measure: Total duration of IV salbutamol treatment in hours
timeFrame: Through study completion, an average 48 hours
measure: Occurrence/frequency of side effects
timeFrame: Through study completion, an average 48 hours
measure: Length of Stay on PICU in days
timeFrame: Through study completion, an average 72 hours
measure: Use of co-medication
timeFrame: Through study completion, an average 72 hours
measure: Use of/duration of non-invasive mechanical ventilation in days
timeFrame: Through study completion, an average 72 hours
measure: DNA polymorphism of the ADRB2-receptor gene
timeFrame: Through study completion, an average 1 year
measure: Use of/duration of non-invasive/invasive mechanical ventilation in days
timeFrame: Through study completion, an average 72 hours
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: