Clinical trial NCT02498496: Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
AECOPD
Magnesium Sulfate
Acute exacerbation of COPD
Chronic Obstructive Pulmonary Disease
ED
ER
Emergency Department
Lead sponsor: Hôpital de Verdun
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Admissions for AECOPD
timeFrame: baseline
Secondary outcomes:
measure: Recurrence of AECOPD
timeFrame: 10, 30, 90 days after hospital discharge
measure: Mortality of any cause
timeFrame: 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
measure: Length of stay
timeFrame: Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.
Other outcomes:
measure: Respiratory failure requiring intubation
timeFrame: 72 hours after randomization
measure: Respiratory failure requiring non-invasive ventilation
timeFrame: 72 hours after randomization
Locations:
Study officials:
affiliation: Hôpital de Verdun
name: Ivan Pavlov, MD
role: PRINCIPAL_INVESTIGATOR
References: