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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02498496
• Other study ID #: MG-1
• Status: Withdrawn
• Phase: Phase 4
• First received: July 7, 2015
• Last updated: February 20, 2018
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Hôpital de Verdun
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Magnesium Sulfate
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
• Placebo
Administration of 100 mL of Normal Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de Verdun

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory failure requiring intubation	Number of patients who require endotracheal intubation	72 hours after randomization
Other	Respiratory failure requiring non-invasive ventilation	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
Primary	Percentage of Admissions for AECOPD	Number of patients admitted to hospital	baseline
Secondary	Recurrence of AECOPD	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
Secondary	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
Secondary	Length of stay	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.