Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ED, ER, Emergency Department
Brief summary
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
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.
Interventions
DRUGMagnesium Sulfate
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
DRUGPlacebo
Administration of 100 mL of Normal Saline
Sponsors
Hôpital de Verdun
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current or previous smoking for at least 10 pack-years * Confirmed COPD : 1. reported by the patient if already diagnosed in the past by a pulmonary disease specialist or on the basis of respiratory function tests; or 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Admissions for AECOPD | baseline | Number of patients admitted to hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of AECOPD | 10, 30, 90 days after hospital discharge | 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. |
| 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. | Measured in hours, from baseline to discharge, either from ED, or after hospital admission |
Other
| Measure | Time frame | Description |
|---|---|---|
| Respiratory failure requiring intubation | 72 hours after randomization | Number of patients who require endotracheal intubation |
| Respiratory failure requiring non-invasive ventilation | 72 hours after randomization | 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 |
Outcome results
None listed