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Magnesium Trial in Acute Asthma in Emergency Department

RecruitingPhase 3Ages 2 Years - 17 YearsAllSuzanne Schuh
NCT06785272 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Despite optimal initial emergency department (ED) therapy, 50% of children with severe acute asthma have ongoing moderate-severe respiratory distress. Guidelines recommend intravenous magnesium (IVMg) for them, yet evidence for IVMg efficacy is scant and disparate. While early small Randomized Controlled Trials (RCTs) suggested hospitalization benefit, recent large observational studies found no association between IVMg and improved outcomes. IVMg therapy is resource-intensive, can cause hypotension and demands close monitoring. Previous RCTs only assessed early Mg effect at 1-2 hours, overlooked the peak effect of key co-interventions such as corticosteroids and did not use validated scores. IVMg use is variable and often delayed until ≥4 hours after ED therapy is started and after the hospitalization decision has been made. Thus, in observational studies children given IVMg are 6-10 ti

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📋 Eligibility rules (as published)
Inclusion criteria: 1. Age 2.00-17.99 years (prior to 18th birthday), 2. Diagnosis of asthma, defined as an asthma or probable asthma diagnosis/asthma-like phenotype made by a physician (this includes ED physician) in a patient who in the opinion of the treating ED physician requires therapy for acute asthma in the ED (GINA asthma guidelines, 2024). 3. Moderate-severe asthma after initial therapy with 3 treatments of inhaled salbutamol and ipratropium, defined as an eligibility PRAM ≥5, indicating a strong association with hospitalization. Exclusion criteria: 1. Receipt of IVMg within 24 hours prior to ED arrival. 2. Need for airway support on arrival. (Airway support on arrival meeting exclusion criteria will include immediate need for high flow nasal cannula therapy, non-invasive CPAP/bi-PAP ventilation or invasive ventilation with endotracheal intubation, as decided by the attending Emergency Department (ED) physician. Supplemental oxygen therapy will not represent an exclusion criterion.) 3. Known renal, chronic pulmonary, neurologic, cardiac or systemic disease: these may influence outcomes after Mg. 4. Known hypersensitivity to Mg sulfate. 5. Previous enrollment. 6. Poor mastery of English and/or French language precluding informed consent understanding. 7. No phone/email; unavailable for follow-up
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What it tests

  • magnesium sulfate
  • Normal Saline
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Where

6 sites
Alberta Children's Hospital
Calgary, Canada
Stollery Children's Hospital
Edmonton, Canada
McMaster Children's Hospital
Hamilton, Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
The Hospital for Sick Children
Toronto, Canada
CHU-Sainte Justine Hospital
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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