Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED (HIMAG-ED-STAT)
August 27, 2026 updated by: Kumpol Kornthatchapong, Thammasat University
Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion Compared With Standard Intravenous Magnesium Sulfate Therapy in Patients With Status Asthmaticus in the Emergency Department
The goal of this clinical is to compare treatment outcomes between high dose continuous IV Magnesium and standard therapy in the management of acute exacerbation of asthma in the emergency department.
Participants will random assign to either high dose continuous IV drip or standard infusion.
Participants in the intervention group received high-dose 50% magnesium sulfate (MgSO4), consisting of 2 g + normal saline (NSS) 100 ml administered intravenously over 30 minutes, followed by MgSO4 6 g + NSS 350 ml infused over 3.5 hours (approximately 40-50 mg/kg/h).
In contrast, participants in the control group received standard-dose 50% MgSO4, consisting of 2 g + NSS 100 ml administered intravenously over 30 minutes, followed by a NSS 350 ml infusion over 3.5 hours.
Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests.
Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge.
Adverse events are documented.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kumpol Kornthatchapong, Associated Professor, MD.Ph.D.
- Phone Number: +6629269316
- Email: kump29@gmail.com
Study Contact Backup
- Name: Department of Emergency Medicine Faculty of Medicine
- Phone Number: +6629269316
- Email: kump29@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged ≥18 years with a known diagnosis of asthma, and
- Presence of signs and symptoms consistent with acute asthma exacerbation, including dyspnea, tachypnea, respiratory distress, chest tightness, cough, or wheezing, and
- Indication for administration of intravenous magnesium sulfate (MgSO4)
Exclusion Criteria:
- Patients requiring endotracheal intubation at the time of initial presentation
- Hypermagnesemia (more than 2.5 mg/dL)
- Known hypersensitivity to magnesium sulfate
- Diagnosed or suspected myasthenia gravis or neuromuscular disease
- Suspected infection meeting the criteria for patients under investigation (PUI) for coronavirus disease 2019 (COVID-19)
- Suspected or confirmed pulmonary tuberculosis
- inability to perform pulmonary function testing (spirometry or peak expiratory flow)
- known case chronic kidney disease (eGFR <30 mL/min/1.73 m²), heart block, pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High dose MgSO4 Continuous IV drip
Participants in the intervention group received high-dose 50% magnesium sulfate (MgSO₄), consisting of 2 g diluted in 100 mL normal saline (NSS) administered intravenously over 30 minutes, followed by MgSO₄ 6 g diluted with NSS up to a total volume of 350 mL infused intravenously over 3.5 hours (approximately 40-50 mg/kg/h).
|
Participants in the intervention group received high-dose 50% magnesium sulfate (MgSO₄), consisting of 2 g diluted in 100 mL normal saline (NSS) administered intravenously over 30 minutes, followed by MgSO₄ 6 g diluted with NSS up to a total volume of 350 mL infused intravenously over 3.5 hours (approximately 40-50 mg/kg/h).
Participants in the control group received standard-dose 50% MgSO₄, consisting of 2 g diluted in 100 mL NSS administered intravenously over 30 minutes, followed by 350 mL NSS infused over 3.5 hours
|
|
Active Comparator: standard-dose MgSO4 Continuous IV drip
Participants in the control group received standard-dose 50% MgSO₄, consisting of 2 g diluted in 100 mL NSS administered intravenously over 30 minutes, followed by 350 mL NSS infused over 3.5 hours
|
Participants in the intervention group received high-dose 50% magnesium sulfate (MgSO₄), consisting of 2 g diluted in 100 mL normal saline (NSS) administered intravenously over 30 minutes, followed by MgSO₄ 6 g diluted with NSS up to a total volume of 350 mL infused intravenously over 3.5 hours (approximately 40-50 mg/kg/h).
Participants in the control group received standard-dose 50% MgSO₄, consisting of 2 g diluted in 100 mL NSS administered intravenously over 30 minutes, followed by 350 mL NSS infused over 3.5 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of ED stay (hours)
Time Frame: through study completion, an average of 1 year
|
Length of ED stay was defined as the time from administration of the first nebulized treatment to the time of physician-ordered disposition from the emergency department.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital admission rate (%)
Time Frame: through study completion, an average of 1 year
|
Hospital admission rate (%) was defined as admission to an inpatient ward or intensive care unit directly from emergency department following the index visit.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
April 30, 2028
Study Registration Dates
First Submitted
August 24, 2026
First Submitted That Met QC Criteria
August 27, 2026
First Posted (Actual)
August 31, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTU-EC-EM-0-176/69
- Pending (Other Grant/Funding Number: National Institutes of Allery and Infectious Diseases)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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