Status Asthmaticus on the PICU; Intravenous Salbutamol

Phase 4

Completed

• Conditions: Childhood Asthma With Status Asthmaticus
• Interventions: Drug: Sodium Chloride 0.9%; Drug: Salbutamol

• Registration Number: NCT03493503
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-05
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Primary Completion: 2019-05-21
• Study Completion: 2019-05-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride 0.9%	Sodium Chloride 0.9%	10 ml of Sodium Chloride 0.9% in 10 minutes.
Salbutamol loading dose	Salbutamol	Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Use of/duration of non-invasive mechanical ventilation in days	Through study completion, an average 72 hours
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
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.
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

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands