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financing delays
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Experimental | Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min. |
|
| Placebo | Placebo Comparator | Administration of a bolus dose of 100 mL of Normal Saline, in 20 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Administration of a bolus of 2 g of MgSO4 in 20 min, one dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Admissions for AECOPD | Number of patients admitted to hospital | baseline |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory failure requiring intubation | Number of patients who require endotracheal intubation | 72 hours after randomization |
| Respiratory failure requiring non-invasive ventilation | Number of patients who require non-invasive ventilation (CPAP, bilevel positive airway pressure (BiPAP) , Optiflow), excluding patients who were using non-invasive ventilation before baseline |
Inclusion Criteria:
Current or previous smoking for at least 10 pack-years
Confirmed COPD :
Patient requires at least one dose of albuterol (salbutamol).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Pavlov, MD | Hôpital de Verdun | Principal Investigator |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Placebo | Drug | Administration of 100 mL of Normal Saline |
|
|
| 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. |
| 72 hours after randomization |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |