Status Asthmaticus on the PICU; Intravenous Salbutamol (STATIC IV)

Erasmus University

Status and phase

Completed

Phase 4

Conditions

Childhood Asthma With Status Asthmaticus

Treatments

Drug: Salbutamol

Drug: Sodium Chloride 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT03493503

NL55029.078.16

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

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