Critical IllnessPhase 4ATOMICNCT05829317
Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
A Phase 4 study testing Magnesium sulfate in people with Critical Illness and New Onset Atrial Fibrillation, run by Dr. Stephanie Sibley at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, New Onset Atrial Fibrillation
- 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
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- 20 Aug 2023to 1 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 enrolment
- On oral or continuous infusion of Amiodarone
- Unlikely to survive >24 hours or palliative patients
- Cardiac surgery patients
Show all 11Show fewer
- Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
- Patients receiving dialysis
- Positive pregnancy test (females <50 years old)
- Previously enrolled in this trial
- Treating physician refuses enrollment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 1Y3
Dr. Deborah Cook, MD
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
Miranda Hunt, 613 549 9999 ext. 3190, miranda.hunt@kingstonhsc.ca
Stephanie Sibley, MD
- Not yet recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Dr. Andrew Seely, MD
- Not yet recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Andrew Seely, MD
About this study
Official title: Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
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.
Read the detailed description
Most studies of new onset atrial fibrillation (NOAF) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. Parenteral Mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of NOAF in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. The main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.
- Conditions
- Critical Illness, New Onset Atrial Fibrillation
- Being tested
- Magnesium sulfate, Placebo
- Keywords
- Prophylaxis, Prevention
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Intravenous Magnesium sulfate
PlaceboDrug
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Experimental | 4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses Receives: Drug: Magnesium sulfate |
| 0.9% NaCl | Placebo comparator | 100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RCT Feasibility
To assess feasibility of patient recruitment, randomization procedures, intervention and data collection and measure protocol adherence. Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 18 hours (+1hr window) of 1st ICU intervention (life sustaining therapy) delivery of all additional
Measured: 90 days
RCT Feasibility
Recruitment rate of ≥ 2 patients/month/ICU
Measured: 90 days
Secondary outcomes (5)
Equipoise and Feasibility
Physician willingness to recruit patients in the setting of existing electrolyte replacement protocols; effectiveness of blinding; proportion of patients who meet eligibility criteria of those admitted to ICU; proportion of eligible patients for whom consent is obtained; proportion of patients who re-consent when they regain capacity for those randomized under the deferred consent model; proportion of patients lost to follow-up; time for research personnel to complete study related tasks.
Measured: 365 days
Acute Care Outcomes
Total number of patients developing AF within 28 days of enrolment (AF will be defined as at least 30 seconds of NOAF detected by cardiac monitoring or ECG); Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants, bleeding events, thromboembolic events (as defined in the 2018 Canadian Stroke Best Practices Guideline1; these will be adjudicated by a neurologist blinded to study groups), persistent organ dysfunction, mortality
Measured: 28 days
Hospital Outcomes
Days alive and ventilator free, ICU length of stay, and hospital length of stay.
Measured: 28 days
Adverse Events
Adverse drug reactions including bradycardia (HR <60 bpm); severe bradycardia (HR <50 bpm); clinically significant bradycardia (bradycardia requiring inotropes, vasopressors, external pacing, temporary pacemaker, or discontinuation of the trial medication); hypotension (MAP< 65mmHg, or systolic blood pressure [SBP]>20mmHg below admission baseline); clinically significant hypotension (hypotension requiring vasopressors, fluid administration, or discontinuation of the trial medication) while the study drug is being infused.
Measured: 28 days
Functional Outcomes
EQ-5D score, death after discharge.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start20 Aug 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Stephanie Sibley
- Sponsor type
- University, hospital or other
- Collaborators
- Southeastern Ontario Academic Medical Organization (SEAMO), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Dr. Stephanie Sibley, Queen's University
- Investigators
- Stephanie Sibley, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829317
- Sponsor's protocol ID
- ATOMIC
- Acronym
- ATOMIC
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05829317
- Acronym / sponsor ID
- ATOMIC / ATOMIC
- Conditions
- Critical Illness, New Onset Atrial Fibrillation
- Keywords
- Prophylaxis, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Stephanie SibleyUniversity, hospital or other
- Collaborators
- Southeastern Ontario Academic Medical Organization (SEAMO), Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Apr 2023 (actual)
- 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.
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.
Detailed description
Most studies of new onset atrial fibrillation (NOAF) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. Parenteral Mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of NOAF in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. The main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Experimental | Drug: Magnesium sulfate4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses |
| 0.9% NaCl | Placebo comparator | Drug: Placebo100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Admitted to an ICU with one or more of the following:
- Continuous cardiac monitoring.
Key exclusion criteria (11 listed)
- 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 enrolment
- On oral or continuous infusion of Amiodarone
- Unlikely to survive >24 hours or palliative patients
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 sulfateIntravenous Magnesium sulfate | Drug | Magnesium Sulfate |
| Placebo0.9% NaCl | Drug | 0.9% NaCl |
Primary outcome
RCT Feasibility
Time frame: 90 days
To assess feasibility of patient recruitment, randomization procedures, intervention and data collection and measure protocol adherence. Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 18 hours (+1hr window) of 1st ICU intervention (life sustaining therapy) delivery of all additional
RCT Feasibility
Time frame: 90 days
Recruitment rate of ≥ 2 patients/month/ICU
5 secondary outcomes
Equipoise and Feasibility
Time frame: 365 days
Acute Care Outcomes
Time frame: 28 days
Hospital Outcomes
Time frame: 28 days
Adverse Events
Time frame: 28 days
Functional Outcomes
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Stephanie Sibley, MD principal investigator
Queen's University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate in people with Critical Illness and New Onset Atrial Fibrillation, run by Dr. Stephanie Sibley at 4 sites in Canada.
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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda Hunt (613 549 6666 ext. 3190, miranda.hunt@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RCT Feasibility (time frame: 90 days). The study lists 2 primary outcomes in all. 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 Sep 2025.