Trial | NCT02498496  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Sep 30
2016
Primary Completion
Oct 31
2017
Anticipated
Study Completion
Nov 30
2017
Anticipated
Last Update
Feb 22
2018

Drug Magnesium Sulfate

Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.

  • Other names: Magnesium Sulfate Injection 50% Baxter. Number 5430

Drug Placebo

Administration of 100 mL of Normal Saline

  • Other names: Normal saline 0.9 % Baxter 50 mL.

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.

Criteria 

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.
No Results Posted