Efficacy of High-Dose Continuous Intravenous Magnesium Sulfate Infusion vs Standard Intravenous Magnesium Sulfate Therapy in Status Asthmaticus in the ED (HIMAG-ED-STAT)
2026年8月27日 更新者：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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kumpol Kornthatchapong, Associated Professor, MD.Ph.D.
- 电话号码：+6629269316
- 邮箱：kump29@gmail.com
研究联系人备份
- 姓名：Department of Emergency Medicine Faculty of Medicine
- 电话号码：+6629269316
- 邮箱：kump29@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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
|
|
有源比较器：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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of ED stay (hours)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital admission rate (%)
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2027年11月1日
研究完成 (估计的)
2028年4月30日
研究注册日期
首次提交
2026年8月24日
首先提交符合 QC 标准的
2026年8月27日
首次发布 (实际的)
2026年8月31日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.