Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED

NCT07795970 | Not Yet Recruiting DMC

• 2 other identifiers: MTU-EC-EM-0-176/69pending
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma Exacerbation; Emergency Department; Magnesuim Sulfate; High Dose

Keywords

asthma exacerbation; magnesium sulfate; emergency department

Outcome Measures

Primary Outcomes (1)

• Length of ED stay (hours)

  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 Outcomes (1)

• Hospital admission rate (%)

  through study completion, an average of 1 year

Study Arms (2)

High dose MgSO4 Continuous IV drip

EXPERIMENTAL

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).

Drug: ้High-dose Magnesium sulphate; Drug: standard-dose Magnesium Sulfate

standard-dose MgSO4 Continuous IV drip

ACTIVE COMPARATOR

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

Drug: ้High-dose Magnesium sulphate; Drug: standard-dose Magnesium Sulfate

Interventions

้High-dose Magnesium sulphate DRUG

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).

High dose MgSO4 Continuous IV drip; standard-dose MgSO4 Continuous IV drip

standard-dose Magnesium Sulfate DRUG

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

High dose MgSO4 Continuous IV drip; standard-dose MgSO4 Continuous IV drip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

Related Links

• Characteristics and outcomes of treatment in status asthmaticus patients at emergency department
• . Role of Intravenous Magnesium in the Management of Moderate to Severe Exacerbation of Asthma: A Literature Review

MeSH Terms

Conditions

Emergencies

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Kumpol Kornthatchapong, Associated Professor, MD.Ph.D.

CONTACT

+6629269316; kump29@gmail.com

Department of Emergency Medicine Faculty of Medicine

CONTACT

+6629269316; kump29@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: randomized controlled trial - RCT

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share