MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of Admissions for AECOPD
研究概览
简要总结
The purpose of this study is to assess whether administration of a bolus dose of MgSO4 (magnesium sulfate) plus standard therapy is superior to standard therapy alone for the management of Acute Exacerbations of Chronic Pulmonary Obstructive Disease (AECOPD) in the emergency department. The investigators hypothesize that MgSO4 causes faster recovery of the bronchospasm, and a reduction of the dead space, translating to the following clinical outcomes : less hospitalisation, lower length of stay (LOS), better composite outcome of hospitalisation + LOS + readmission for AECOPD.
详细描述
Patients presenting to the participant Emergency Departments (ED) with a diagnosis of AECOPD and who receive at least one dose of albuterol, will be randomized to receive either placebo or one dose of MgSO4 2g IV. Security and efficacy outcomes will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current or previous smoking for at least 10 pack-years
- •Confirmed COPD :
- •reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or
- •new diagnosis in the ED, with confirmatory pulmonary tests showing Forced Expiratory Volume (FEV1) / Forced Vital Capacity (FVC) ratio < 70% and FEV1< 80%
- •Patient requires at least one dose of albuterol (salbutamol).
排除标准
- •Dialysis patients
- •Severe kidney disease, known or suspected to have a creatine clearance <
- •Metastatic neoplasm
- •Patients who received IV MgSO4 in the last week.
- •Hypotension, defined as systolic blood pressure less than 90.
研究组 & 干预措施
Placebo
Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
干预措施: Placebo (Drug)
Magnesium Sulfate
Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Percentage of Admissions for AECOPD
时间窗: baseline
Number of patients admitted to hospital
次要结局
- Mortality of any cause(Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and for 30 days after discharge, up to 1 year after randomization)
- Length of stay(Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.)
- Recurrence of AECOPD(10, 30, 90 days after hospital discharge)
研究者
Ivan Pavlov
Emergency Physician
Hôpital de Verdun