Timely Administration of IV Magnesium Sulfate in Patients With a Moderate Asthma Exacerbation

Early Phase 1

Recruiting

• Conditions: Asthma Attack; Asthma in Children
• Interventions: Drug: Magnesium Sulfate within the first hour; Other: No Magnesium sulfate within the first hour

• Registration Number: NCT06137040
• Lead Sponsor: University of Oklahoma

Brief Summary

This study aims to identify whether early administration of magnesium sulfate in moderate asthma exacerbations can potentially avoid admission, decrease length of stay in the emergency department (ED), decrease length of stay (LOS) in the general hospital floor vs pediatric intensive care unit (PICU), and decrease the need for respiratory support.

Detailed Description

Patients ages 5-17 presenting to the OU Children's Hospital Emergency Department from October 2023 to July 2024 will be assigned a respiratory score (RS) upon presentation. Those with a RS between 6-9 (moderate exacerbation) will be screened for inclusion. Eligible patient will then be approached for consent. First line asthma therapies including bronchodilators and steroids will not be delayed for the consent process. Patients who consent will be randomized to the control vs. experimental group once consent is obtained.

The study will not be blinded once a patient is randomized to a group, the provider will know whether the patient will receive weight-based IV magnesium within the first hour (experimental group) or receive standard weight-based IV magnesium sulfate per the provider's clinical judgement (placebo group). Magnesium sulfate dosing for the experimental group will be as follows:

15-19 kg: 750 mg

20-29 kg: 1000 mg

30-39 kg: 1500 mg

\>40 kg: 2000 mg

Enrolled patients will have their clinical course reviewed and data obtained regarding LOS in ED and hospital stay, need for respiratory support, and or PICU LOS if applicable.

Study Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2023-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Ages 5-17 years old
• Presents to the ED with a respiratory score in the "Moderate" range (6
• Parent(s)/Caregiver(s) speak English

Exclusion Criteria

• Patients with chronic medical conditions including chronic pulmonary disease (other than asthma), cerebral palsy, congenital heart disease, tracheostomy dependent, myasthenia gravis patients
• Patients who are pregnant
• Parent(s)/Caregiver(s) do not speak English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate in the first hour	Magnesium Sulfate within the first hour	These patients will receive 40-50 mg/kg IV magnesium sulfate within the first hour of treatment alongside all first line asthma exacerbation therapies (ie inhaled beta agonists, IV steroids).
No Magnesium Sulfate	No Magnesium sulfate within the first hour	These patients will not receive IV magnesium sulfate within the first hour of treatment but may receive it later if the provider feels it is clinically necessary.

Primary Outcome Measures

Name	Time	Method
Change in Length of Stay in Patients who receive IV Magnesium within the first hour (experimental group) vs control group	From initiation of therapy to discharge from the emergency department or admitting unit, up to 1 week	Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can reduce length of stay in the ED, general hospital bed or PICU. The data will also be analyzed to determine if more patients in the experimental group were able to be discharged from the emergency department compared to the control group.

Secondary Outcome Measures

Name	Time	Method
Evaluate the need for respiratory support in patients receiving magnesium sulfate within the first hour (experimental group) vs control group	Time of initiation of therapy to discharge from the hospital, up to 2 weeks	Evaluating whether timely administration of IV magnesium sulfate in moderate asthma exacerbations can decrease the need for respiratory support including invasive and non-invasive respiratory support devices.

Trial Locations

Locations (1)

Oklahoma Children's Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States