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

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ClinicalTrials.gov Identifier: NCT03493503
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Matthijs de Hoog, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE April 10, 2018
Last Update Posted Date April 10, 2018
Actual Study Start Date  ICMJE April 5, 2017
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
Reduction Asthma score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Cumulative dose of IV salbutamol [ Time Frame: Through study completion, an average 48 hours ]
  • Maximum infusion rate of IV salbutamol in mcg/kg/min [ Time Frame: Through study completion, an average 48 hours ]
  • Total duration of IV salbutamol treatment in hours [ Time Frame: Through study completion, an average 48 hours ]
  • Occurrence/frequency of side effects [ Time Frame: Through study completion, an average 48 hours ]
  • Length of Stay on PICU in days [ Time Frame: Through study completion, an average 72 hours ]
  • Use of co-medication [ Time Frame: Through study completion, an average 72 hours ]
  • Use of/duration of non-invasive mechanical ventilation in days [ Time Frame: Through study completion, an average 72 hours ]
  • DNA polymorphism of the ADRB2-receptor gene [ Time Frame: 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 [ Time Frame: Through study completion, an average 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Status Asthmaticus on the PICU; Intravenous Salbutamol
Official Title  ICMJE Efficacy of a Loading Dose of IV Salbutamol in Children Admitted to a PICU for Severe Acute Asthma or Severe Acute Wheeze
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Childhood Asthma With Status Asthmaticus
Intervention  ICMJE
  • Drug: Salbutamol
    Intravenous Salbutamol loading dose
  • Drug: Sodium Chloride 0.9%
    10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
Study Arms  ICMJE
  • Experimental: Salbutamol loading dose
    Salbutamol loading dose of 15 mcg/kg in 10 minutes, with a maximum of 750 mcg.
    Intervention: Drug: Salbutamol
  • Placebo Comparator: Sodium Chloride 0.9%
    10 ml of Sodium Chloride 0.9% in 10 minutes.
    Intervention: Drug: Sodium Chloride 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shelley Boeschoten, MD 0031630035001 s.boeschoten@erasmusmc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03493503
Other Study ID Numbers  ICMJE NL55029.078.16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthijs de Hoog, Erasmus Medical Center
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Erasmus Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP