STATIC IV: Efficacy of a loading dose of intravenous salbutamol in patients admitted to a PICU for severe acute asthma

Phase 4

Completed

Conditions: life-threatening asthma attack
10006436
Status asthmaticus

Registration Number: NL-OMON43695

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome variable is (reduction of) asthma score (Qureshi) 1 hour<br /><br>after administration of loading dose in the intervention group compared to the<br /><br>placebo group. Based on expert opinion, we consider a reduction of 2 points to<br /><br>represent a clinically relevant improvement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The (reduction of) asthma score (Qureshi) 6 hours after administration of<br /><br>loading dose in the intervention group compared to the placebo group.<br /><br>* Cumulative dose of IV salbutamol<br /><br>* Maximum infusion rate of IV salbutamol in mcg/kg/min<br /><br>* Total duration of IV salbutamol treatment in hours<br /><br>* Occurrence/frequency of side effects (categorical) (Tachycardia, Arrhythmia,<br /><br>Hypotension, Hypokalaemia, Hyperglycaemia, Lactic acidosis)<br /><br>* Length of Stay on PICU in days<br /><br>* Use of co-medication + dosage + timing (e.g. sodium bicarbonate,<br /><br>theophylline, sevoflurane)<br /><br>* Use of prednisone + time/method of first administration<br /><br>* Use of/duration of non-invasive/invasive mechanical ventilation in days<br /><br>* Distribution of ADRB2-receptor polymorphisms (SNPs for Arginine and Glycine<br /><br>on chromosomes 16 and 27) compared to normal population (non-SAA)</p><br>