Erasmus MC
Rotterdam, South Holland, 3000WB, Netherlands
Completed
NCT Number: NCT03493503
Status Asthmaticus on the PICU; Intravenous Salbutamol
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.
Completed
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Notify MeKey information
Conditions
Age range
2 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Salbutamol
DrugIntravenous Salbutamol loading dose
Sodium chloride 0.9%
Drug10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
Primary outcomes
-
Reduction Asthma score
Time frame: 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.
Secondary outcomes
-
Cumulative dose of IV salbutamol
Time frame: Through study completion, an average 48 hours
-
Maximum infusion rate of IV salbutamol in mcg/kg/min
Time frame: Through study completion, an average 48 hours
-
Total duration of IV salbutamol treatment in hours
Time frame: Through study completion, an average 48 hours
-
Occurrence/frequency of side effects
Time frame: Through study completion, an average 48 hours
-
Length of Stay on PICU in days
Time frame: Through study completion, an average 72 hours
-
Use of co-medication
Time frame: Through study completion, an average 72 hours
-
Use of/duration of non-invasive mechanical ventilation in days
Time frame: Through study completion, an average 72 hours
-
DNA polymorphism of the ADRB2-receptor gene
Time frame: Through study completion, an average 1 year
The investigators will look at DNA, if there is a polymorphism in the ADRB2-receptor gene. If there is a polymorphism it can cause downregulation of the adrenergic B2 receptors.
-
Use of/duration of non-invasive/invasive mechanical ventilation in days
Time frame: Through study completion, an average 72 hours
Sponsors and collaborators
Lead sponsor
Erasmus Medical Center
Other
Registry information
Official study title
Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
Acronym: STATIC IV
Important dates
- Study start
- 2017
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Apr 10, 2018
- Registry last updated
- Jul 30, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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