STATIC IV: Status Asthmaticus on the PICU; Intravenous Salbutamol
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Salbutamol loading dose Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg. |
Drug: Salbutamol
Intravenous Salbutamol loading dose
|
| Placebo Comparator: Sodium Chloride 0.9% 10 ml of Sodium Chloride 0.9% in 10 minutes. |
Drug: Sodium Chloride 0.9%
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
|
Outcome Measures
Primary Outcome Measures
- Reduction Asthma score [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 Outcome Measures
- 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]
- Total duration of IV salbutamol treatment in hours [Through study completion, an average 48 hours]
- Occurrence/frequency of side effects [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]
- 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]
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 [Through study completion, an average 72 hours]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus MC | Rotterdam | Zuid-Holland | Netherlands | 3000WB |
Sponsors and Collaborators
- Erasmus Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL55029.078.16