- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498496
Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
February 20, 2018 updated by: Ivan Pavlov, Hôpital de Verdun
MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
33 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Magnesium Sulfate
Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min.
|
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
Other Names:
|
Placebo Comparator: Placebo
Administration of a bolus dose of 100 mL of Normal Saline, in 20 min.
|
Administration of 100 mL of Normal Saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Admissions for AECOPD
Time Frame: baseline
|
Number of patients admitted to hospital
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of AECOPD
Time Frame: 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.
|
10, 30, 90 days after hospital discharge
|
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
|
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
Time Frame: 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
|
Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory failure requiring intubation
Time Frame: 72 hours after randomization
|
Number of patients who require endotracheal intubation
|
72 hours after randomization
|
Respiratory failure requiring non-invasive ventilation
Time Frame: 72 hours after randomization
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 15, 2015
Study Record Updates
Last Update Posted (Actual)
February 22, 2018
Last Update Submitted That Met QC Criteria
February 20, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- MG-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Magnesium Sulfate
-
University of OklahomaRecruitingAsthma in Children | Asthma AttackUnited States
-
Sohag UniversityRecruitingPost Operative Pain, AcuteEgypt
-
Thomas Jefferson UniversityNot yet recruiting
-
Queen Sirikit National Institute of Child HealthUnknownAcute Severe AsthmaThailand
-
Sohag UniversityCompletedPersistent Pulmonary Hypertension of the Newborn | PPHN | Persistent Fetal CirculationEgypt
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedSevere PreeclampsiaBrazil
-
Assiut UniversityCompletedMaternal Care PatternsEgypt
-
Assiut UniversityRecruitingIntracranial Pressure Control in Pre-eclampsiaEgypt
-
University of Texas Southwestern Medical CenterCompletedAsthmaUnited States
-
University of MonastirCompletedAtrial FibrillationTunisia