Pulmonary Disease, Chronic ObstructivePhase 4NCT02498496
Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Magnesium Sulfate in people with Pulmonary Disease, Chronic Obstructive, run by Hôpital de Verdun.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Magnesium Sulfate, Placebo
- Keywords
- COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ED, ER, Emergency Department
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Magnesium Sulfate Injection 50% Baxter. Number 5430
Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
PlaceboDrug
Also called Normal saline 0.9 % Baxter 50 mL.
Administration of 100 mL of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Experimental | Administration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min. Receives: Drug: Magnesium Sulfate |
| Placebo | Placebo comparator | Administration of a bolus dose of 100 mL of Normal Saline, in 20 min. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Admissions for AECOPD
Number of patients admitted to hospital
Measured: baseline
Secondary outcomes (3)
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.
Measured: 10, 30, 90 days after hospital discharge
Mortality of any cause
Measured: 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
Measured in hours, from baseline to discharge, either from ED, or after hospital admission
Measured: Participants will be followed for the duration of the hospital stay, an expected 2 weeks, and up to 1 year after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startSep 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: financing delays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de Verdun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Pavlov, Hôpital de Verdun
- Investigators
- Ivan Pavlov, MD, Principal investigator, Hôpital de Verdun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498496
- Sponsor's protocol ID
- MG-1
- Status last verified
- Feb 2018
- First submitted
- 7 Jul 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MASTER-ED : Magnesium Sulfate to Prevent Hospitalisation of Acute Exacerbations of Chronic Obstructive Pulmonary Disease Seen in the Emergency Department
- ClinicalTrials.gov ID
- NCT02498496
- Acronym / sponsor ID
- MG-1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, AECOPD, Magnesium Sulfate, Acute exacerbation of COPD, Chronic Obstructive Pulmonary Disease, ED, ER, Emergency Department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financing delays
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hôpital de VerdunUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Experimental | Drug: Magnesium SulfateAdministration of a bolus dose of 2 g of MgSO4 in 100 mL of Normal Saline IV, in 20 min. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of a bolus dose of 100 mL of Normal Saline, in 20 min. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or previous smoking for at least 10 pack-years
- Confirmed COPD :
- Patient requires at least one dose of albuterol (salbutamol).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: Magnesium Sulfate Injection 50% Baxter. Number 5430Administration of a bolus of 2 g of MgSO4 in 20 min, one dose. | Drug | Magnesium Sulfate |
| PlaceboAlso: Normal saline 0.9 % Baxter 50 mL.Administration of 100 mL of Normal Saline | Drug | Placebo |
Primary outcome
Percentage of Admissions for AECOPD
Time frame: baseline
Number of patients admitted to hospital
3 secondary outcomes
Recurrence of AECOPD
Time frame: 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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Pavlov, MD principal investigator
Hôpital de Verdun
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate in people with Pulmonary Disease, Chronic Obstructive, run by Hôpital de Verdun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Admissions for AECOPD (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.