Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ED, ER, Emergency Department
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium Sulfate
Placebo
Arm Description
Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
Outcomes
Primary Outcome Measures
Percentage of Admissions for AECOPD
Number of patients admitted to hospital
Secondary Outcome Measures
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.
Mortality of any cause
Length of stay
Measured in hours, from baseline to discharge, either from ED, or after hospital admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498496
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
financing delays
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital de Verdun
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ED, ER, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Sulfate
Arm Type
Experimental
Arm Description
Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Magnesium Sulfate Injection 50% Baxter. Number 5430
Intervention Description
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline 0.9 % Baxter 50 mL.
Intervention Description
Administration of 100 mL of Normal Saline
Primary Outcome Measure Information:
Title
Percentage of Admissions for AECOPD
Description
Number of patients admitted to hospital
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Recurrence of AECOPD
Description
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.
Time Frame
10, 30, 90 days after hospital discharge
Title
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
Title
Length of stay
Description
Measured in hours, from baseline to discharge, either from ED, or after hospital admission
Time Frame
Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.
Other Pre-specified Outcome Measures:
Title
Respiratory failure requiring intubation
Description
Number of patients who require endotracheal intubation
Time Frame
72 hours after randomization
Title
Respiratory failure requiring non-invasive ventilation
Description
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
Time Frame
72 hours after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Pavlov, MD
Organizational Affiliation
Hôpital de Verdun
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
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