Status Asthmaticus on the PICU; Intravenous Salbutamol

Childhood Asthma With Status Asthmaticus Clinical Trial

— STATIC IV  

Official title:

Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493503
• Other study ID #: NL55029.078.16
• Status: Completed
• Phase: Phase 4
• Start date: April 5, 2017
• Est. completion date: May 21, 2019

Study information

• Verified date: July 2020
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 21, 2019
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma With Status Asthmaticus
• Status Asthmaticus

Intervention

Drug:
• Salbutamol
Intravenous Salbutamol loading dose
• Sodium Chloride 0.9%
10 ml of Sodium Chloride 0.9% in 10 minutes intravenous

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction Asthma score	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.	First 24 hours after admission on the PICU
Secondary	Cumulative dose of IV salbutamol		Through study completion, an average 48 hours
Secondary	Maximum infusion rate of IV salbutamol in mcg/kg/min		Through study completion, an average 48 hours
Secondary	Total duration of IV salbutamol treatment in hours		Through study completion, an average 48 hours
Secondary	Occurrence/frequency of side effects		Through study completion, an average 48 hours
Secondary	Length of Stay on PICU in days		Through study completion, an average 72 hours
Secondary	Use of co-medication		Through study completion, an average 72 hours
Secondary	Use of/duration of non-invasive mechanical ventilation in days		Through study completion, an average 72 hours
Secondary	DNA polymorphism of the ADRB2-receptor gene	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.	Through study completion, an average 1 year
Secondary	Use of/duration of non-invasive/invasive mechanical ventilation in days		Through study completion, an average 72 hours