Pilot Study of Magnesium Infusions in Pediatric Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Magnesium Infusions (Drips) for Moderate-to-Severe Pediatric Asthma Exacerbations

Conditions
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Asthma

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium<br>Half the enrolled subjects will be randomized to receive active drug, a magnesium infusion. | Drug: Magnesium Sulfate<br>* Continuous magnesium drip, titrated to effect until patient's symptoms improve<br>|
| Placebo Comparator: Control<br>Half the subjects will be randomized to receive a drip that does not have active drug (magnesium sulfate). | Drug: Placebo<br>* Simple saline drip, without active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | The primary outcome for this study is elapsed time from emergency department (ED) presentation to readiness for PICU discharge. | Duration of hospital stay, typically 3-5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta receptor haplotype | 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. | Once on enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Magnesium, Adrenergic Receptor