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

Hôpital de Verdun

Status and phase: Withdrawn; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Magnesium Sulfate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02498496

MG-1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Magnesium Sulfate

Experimental group

Description:

Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.

Treatment:

Drug: Magnesium Sulfate

Placebo

Placebo Comparator group

Description:

Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.

Treatment:

Drug: Placebo