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NCT Number: NCT07795970

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

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.

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Key information

Conditions

Asthma Exacerbation Disease Attributes Emergencies Emergency Department High Dose Magnesuim Sulfate Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

้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).

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Department of Emergency Medicine Faculty of Medicine

CONTACT

[email protected]

+6629269316

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

CONTACT

[email protected]

+6629269316

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Acronym: HIMAG-ED-STAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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