Testing Magnesium sulfate against a placebo for critical illness
Official title: Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
- Phase 4
- 2 groups
- Sites in Hamilton, Kingston and 1 more city
- Recruiting
Interventions
- Medication
Magnesium sulfate
Intravenous Magnesium sulfate
- Medication
Placebo
0.9% NaCl
Canadian Sites (4)
1 of 4 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Not yet recruiting
St Joseph's Healthcare Hamilton
Hamilton, Ontario
- Not yet recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario
- Not yet recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years;
- +Admitted to an ICU with one or more of the following:
- +Non-invasive ventilation (including CPAP, Bipap and high flow oxygen (\>10L/min) or invasive mechanical ventilation with an expected duration \>24 hours for respiratory failure (hypercarbic or hypoxic)
- +Vasopressor or inotropic support with an expected duration of \>24 hours
- +Cardiac arrest
- +Continuous cardiac monitoring.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for \>18 hours
- +Receiving IMV for airway protection only (for example, isolated head trauma)
- +Active atrial fibrillation at the time of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +On oral or continuous infusion of Amiodarone
- +Unlikely to survive \>24 hours or palliative patients
- +Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
- +Patients receiving dialysis
- +Previously enrolled in this trial
- +Treating physician refuses enrollment
- +Positive pregnancy test (females \<50 years old)
- +Cardiac surgery patients
Exclusion
- −Receiving ICU intervention (Non-invasive ventilation (including high flow nasal canula), invasive mechanical ventilation or inotropic support) for \>18 hours
- −Receiving IMV for airway protection only (for example, isolated head trauma)
- −Active atrial fibrillation at the time of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- −On oral or continuous infusion of Amiodarone
- −Unlikely to survive \>24 hours or palliative patients
- −Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
- −Patients receiving dialysis
- −Previously enrolled in this trial
- −Treating physician refuses enrollment
- −Positive pregnancy test (females \<50 years old)
- −Cardiac surgery patients
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Magnesium sulfate.
Registry label: A: Magnesium Sulfate
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: 0.9% NaCl
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 200 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: 90 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
RCT Feasibility — measured over 90 days.
RCT Feasibility — measured over 90 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05829317 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Magnesium sulfateDrug
Intravenous Magnesium sulfate
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
0.9% NaCl
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 90 days.
The study as a whole is currently expected to finish around 2028-07-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.