Asthma
Conditions
Keywords
Asthma, Magnesium, Adrenergic Receptor
Brief summary
This is a prospective randomized pilot study that seeks to address the research question: In children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard Pediatric intensive care unit (PICU)-level asthma care significantly decrease time from patient presentation until PICU discharge?
Detailed description
This study will be a double-blind, prospective randomized pilot study. Subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.
Interventions
DRUGMagnesium Sulfate
Continuous magnesium drip, titrated to effect until patient's symptoms improve
DRUGPlacebo
Simple saline drip, without active drug
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Age 2 years 0 days up to 20 years 364 days * Clinical diagnosis of asthma including both of the following: * Attending physician's primary working diagnosis is status asthmaticus * Results of a modified International Study of Asthma and Allergies in Children (ISAAC) diagnostic questionnaire consistent with an asthma diagnosis * Planned PICU admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater * IV access or equivalent * Ability to understand and give informed consent/assent in English
Exclusion criteria
* Prior enrollment in this study * Prior adverse reactions to magnesium * Use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment * Admission for inpatient asthma care in preceding 2 weeks * Hemodynamic instability, impending respiratory failure or intubation * Inability in children age 7 years or older to give assent due to a developmental delay or altered mental status * Significant renal or cardiac disease * Sickle cell anemia * Significant, active non-asthma pulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge | Duration of hospital stay, typically 3-5 days | The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beta receptor haplotype | Once on enrollment | The subject's genetic haplotype for beta adrenergic receptor. It will be determined by blood test during their admission in the hospital and enrollment on the study protocol. |
Countries
United States
Outcome results
None listed