Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Dialysis patients Severe kidney disease, known or suspected to have a creatine clearance < 15. Metastatic neoplasm Patients who received IV MgSO4 in the last week. Hypotension, defined as systolic blood pressure less than 90.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium Sulfate<br>Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min. | Drug: Magnesium Sulfate<br>* Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.<br>* Other names: Magnesium Sulfate Injection 50% Baxter. Number 5430;|
| Placebo Comparator: Placebo<br>Administration of a bolus dose of 100 mL of Normal Saline, in 20 min. | Drug: Placebo<br>* Administration of 100 mL of Normal Saline<br>* Other names: Normal saline 0.9 % Baxter 50 mL.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Admissions for AECOPD | Number of patients admitted to hospital | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of AECOPD | A composite outcome of (death, re-admission for AECOPD, new visit for AECOPD in the ED) in patients who are discharged either directly from the ED or after admission on the wards. | 10, 30, 90 days after hospital discharge | 
| 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 | Measured in hours, from baseline to discharge, either from ED, or after hospital admission | Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ED, COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ER, Emergency Department