Phase 2 N=52 Randomized Quadruple-blind Treatment

Timely Intravenous Magnesium for Asthma in Children

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT05166811 ↗

Enrolled (actual)

Serious AEs

4.1%

Results posted

Dec 2024

Primary outcome: Primary: Enrollment — 18; 17; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Magnesium Sulfate, Heptahydrate (Drug); 0.9% saline (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Enrollment	18; 17; 17	—
SECONDARY Hospitalization	12; 12; 14	—
SECONDARY Hospitalization Anticipated by Treating Physician 2 Hours After Start of Study Infusion	13; 12; 13	—
SECONDARY Adverse Events and Safety Profiles - Hypotension and Perfusion	2; 1; 1; 2; 4; 3	—
SECONDARY Rescue Therapies Used During ED Care - SQ or IM Epinephrine	1; 1; 0; 17; 16; 17	—
SECONDARY Return ED Visit	5; 0; 1	—
SECONDARY Baseline Serum Magnesium	1.95; 1.95; 2.20	—
SECONDARY Baseline Ionized Magnesium	0.57; 0.57; 0.70	—
SECONDARY Post-infusion Serum Magnesium 1	1.86; 4.13; 3.79	—
SECONDARY Post-infusion Ionized Magnesium 1	0.54; 1.06; 1.15	—
SECONDARY Post-infusion Serum Magnesium 2	1.91; 2.54; 2.84	—
SECONDARY Post-infusion Ionized Magnesium 2	0.57; 0.76; 0.85	—
SECONDARY Rescue Therapies Used During ED Care - IV Epinephrine	0; 0; 0; 18; 17; 17	—
SECONDARY Rescue Therapies Used During ED Care - IV Terbutaline	0; 0; 0; 18; 17; 17	—
SECONDARY Rescue Therapies Used During ED Care - IV Magnesium	2; 2; 4; 16; 15; 13	—
SECONDARY Adverse Events and Safety Profiles - Supraventricular Tachycardia	0; 0; 1; 18; 16; 14	—
SECONDARY Adverse Events and Safety Profiles - Abdominal Discomfort	0; 0; 1; 18; 16; 14	—
SECONDARY Adverse Events and Safety Profiles - Vomiting	0; 0; 1; 18; 16; 14	—
SECONDARY Adverse Events and Safety Profiles - Fatigue	0; 1; 0; 18; 15; 15	—
SECONDARY Adverse Events and Safety Profiles - Hypokalemia	0; 1; 0; 18; 15; 15	—
SECONDARY Adverse Events and Safety Profiles - Delirium	0; 0; 1; 18; 16; 14	—
SECONDARY Adverse Events and Safety Profiles - Hypoxia	1; 1; 2; 17; 15; 13	—
SECONDARY Adverse Events and Safety Profiles - Respiratory Distress	2; 0; 0; 16; 16; 15	—
SECONDARY Adverse Events and Safety Profiles - Metabolic Acidosis	1; 0; 0; 17; 16; 15	—
SECONDARY Adverse Events and Safety Profiles - Duodenal Ulcer Perforation	1; 0; 0; 17; 16; 15	—

Summary

Many children currently being hospitalized with severe asthma could potentially avoid hospitalization and be sent home if their treatment in the emergency department was more effective. The investigators will conduct a pilot trial that will lead to a larger study to conclusively answer whether a simple and inexpensive medicine, intravenous magnesium sulfate, can be used in the emergency department to prevent hospitalization for these children.

Eligibility Criteria

Inclusion criteria are:

A prior physician diagnosis of asthma confirmed by a treating physician in the ED who has spoken with the patient and family and reviewed the medical record (ED attending or fellow physician)
Severe acute asthma, defined as a Pediatric Respiratory Assessment Measure (PRAM) score of 7 or greater as assessed by a treating physician at the time of screening using the study scoring instrument, which takes 60 seconds to complete
Children 2-17 years of age

Exclusion criteria are:

Known pregnancy (by patient or parent report) or positive pregnancy test on females 12 years of age and older
Age-adjusted hypotension at presentation using age-based Pediatric Advanced Life Support parameters (children >1 year to 10 years, systolic blood pressure (SBP) 10 years, SBP < 90 mmHg)71
Known severe renal impairment (by parent or patient report)
Application of assisted ventilation before enrollment assessment (intubated, bi-level positive airway pressure, continuous positive airway pressure)
Received IVMg within 24 hours prior to screening (by parent or patient report or medical record review)
Enrollment assessment is 60 minutes after the start of ED treatment (start of first albuterol treatment)
Previous enrollment in the same trial (by research coordinator review of trial records)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05166811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.