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

February 20, 2018 updated by: Ivan Pavlov, Hôpital de Verdun

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

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.

Study Overview

Status

Withdrawn

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium Sulfate
Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
Other Names:
  • Magnesium Sulfate Injection 50% Baxter. Number 5430
Placebo Comparator: Placebo
Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
Administration of 100 mL of Normal Saline
Other Names:
  • Normal saline 0.9 % Baxter 50 mL.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of AECOPD
Time Frame: 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.
10, 30, 90 days after hospital discharge
Mortality of any cause
Time Frame: 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
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
Time Frame: 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
Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory failure requiring intubation
Time Frame: 72 hours after randomization
Number of patients who require endotracheal intubation
72 hours after randomization
Respiratory failure requiring non-invasive ventilation
Time Frame: 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
72 hours after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

July 7, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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