Timely Intravenous Magnesium for Asthma in Children

NCT05166811 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB 1040821R34HL152047-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Asthma

Keywords

asthma; IV Magnesium

Outcome Measures

Primary Outcomes (1)

• Enrollment

  The primary outcome in this pilot trial is demonstration of the ability to enroll severely ill children with asthma in a randomized trial requiring timely delivery of IVMg or placebo. The investigators anticipate that the primary outcome of the future large trial will be the proportion of children hospitalized at the index visit in each arm.

  7 months of enrollment.

Secondary Outcomes (24)

• Hospitalization

  Actual disposition from chart review 1 week after enrollment.

• Hospitalization Anticipated by Treating Physician 2 Hours After Start of Study Infusion

  Physician-anticipated hospitalization 2 hours after the start of study drug infusion

• Adverse Events and Safety Profiles - Hypotension and Perfusion

  2 hours after study drug infusion.

• Rescue Therapies Used During ED Care - SQ or IM Epinephrine

  One week after enrollment

• Return ED Visit

  Within 10 days after ED discharge

Study Arms (3)

75 mg/kg

ACTIVE COMPARATOR

Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 75 mg/kg arm, this will be accomplished by mixing 37.5 mL of IVMg (80 mg/mL) with 2.5 mL of sterile water for a final concentration of 75 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.

Drug: Magnesium Sulfate, Heptahydrate

50 mg/kg

ACTIVE COMPARATOR

Doses for each IVMg arm will be prepared in identical manner, by drawing a specified volume of IVMg from the commercial container using sterile technique and mixing in a polyvinylchloride container with a specified volume of sterile water. For the 50 mg/kg arm, this will be accomplished by mixing 25 mL of IVMg (80 mg/mL) with 15 mL of sterile water for a final concentration of 50 mg/mL and volume of 40 mL. After randomization the institutional pharmacist will draw dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.

Drug: Magnesium Sulfate, Heptahydrate

Placebo

PLACEBO COMPARATOR

For the placebo arm, 40 mL of 0.9% sodium chloride solution will be drawn into a polyvinylchloride container identical in appearance to the containers used for the IVMg arms. After randomization the institutional pharmacist will draw dosages (1 mL/kg, with max of 40 mL) from previously prepared vials. The dose will be delivered by the clinical nurse over 20 minutes through a peripheral IV.

Drug: 0.9% saline

Interventions

Magnesium Sulfate, Heptahydrate DRUG

A single dose of intravenous magnesium sulfate given over 20 minutes through a peripheral intravenous line. Two arms of the study will deliver intravenous magnesium, one at a dose of 50 mg/kg, and the other at a dose of 75 mg/kg.

Also known as: Intravenous magnesium sulfate

50 mg/kg; 75 mg/kg

0.9% saline DRUG

A single dose of intravenous 0.9% sodium chloride given over 20 minutes through a peripheral intravenous line as the placebo arm of the study.

Also known as: normal saline, 0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)\<(70 + 2 x age in years); \>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)

Sponsors & Collaborators

• University of Utah: lead
• Children's Hospital of Philadelphia: collaborator
• Nationwide Children's Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84010, United States

Location

Related Publications (1)

• Johnson MD, Barney BJ, Rower JE, Finkelstein Y, Zorc JJ. Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED): Protocol for a Multicenter Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 17;12:e48302. doi: 10.2196/48302.

  PMID: 37459153 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Magnesium Sulfate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Results Point of Contact

• Title: Dr. Michael D. Johnson
• Organization: University of Utah

mike.johnson@hsc.utah.edu

(801) 935-0503

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Doses will be prepared ahead of time by an investigational pharmacist, arms will be identical in appearance, and clinicians administering the study drug will be blinded to the study arm the patient receives.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 22, 2021
• Study Start: September 12, 2022
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Locations

US (3)