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

Phase 4

Withdrawn

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo; Drug: Magnesium Sulfate

• Registration Number: NCT02498496
• Lead Sponsor: Hôpital de Verdun

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.

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-15
• Study Start: 2016-09
• Primary Completion: 2017-10
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
Magnesium Sulfate	Magnesium Sulfate	Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.

Primary Outcome Measures

Name	Time	Method
Percentage of Admissions for AECOPD	baseline	Number of patients admitted to hospital

Secondary Outcome Measures

Name	Time	Method
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
Length of stay	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
Recurrence of AECOPD	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.