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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Withdrawn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

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

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

NCT ID

NCT02498496

First Posted

July 7, 2015

Last Updated

February 20, 2018

Sponsor

Hôpital de Verdun

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

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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