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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Length of ED stay (hours)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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).
干预措施: ้High-dose Magnesium sulphate (Drug)
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).
干预措施: standard-dose Magnesium Sulfate (Drug)
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
干预措施: ้High-dose Magnesium sulphate (Drug)
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
干预措施: standard-dose Magnesium Sulfate (Drug)
结局指标
主要结局
Length of ED stay (hours)
时间窗: 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.
次要结局
- Hospital admission rate (%)(through study completion, an average of 1 year)
研究者
Kumpol Kornthatchapong
Associated Professor
Thammasat University