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Electrolyte Supplement

Magnesium Sulfate for Atrial Fibrillation Prevention (ATOMIC Trial)

Phase 4
Recruiting
Led By Stephanie Sibley, MD
Research Sponsored by Queen's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to a critical care unit with EITHER: Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration >24 hours AND/OR Vasopressor or ionotropic support for shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: Dopamine, Dobutamine, Norepinephrine, Epinephrine, Ephedrine, Milrinone at any dose (if used in conjunction with another agent), Vasopressin (if used in conjunction with another agent)
Age ≥18 years
Must not have
Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation
Patients receiving dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if a medicine can prevent a heart rhythm disorder in critically ill patients in intensive care units.

Who is the study for?
This trial is for adults over 18 in critical care needing breathing support or medication for shock. They must be receiving heart monitoring and expected to survive more than 24 hours. Pregnant women, those with current or past atrial fibrillation, patients post-cardiac surgery, on dialysis, or needing magnesium therapy cannot join.
What is being tested?
The study tests if magnesium sulfate can prevent new-onset atrial fibrillation in critically ill ICU patients compared to a placebo. It's a double-blind pilot trial meaning neither the participants nor the researchers know who receives the real treatment.
What are the potential side effects?
Magnesium sulfate may cause flushing, sweating, lowered blood pressure, confusion, muscle weakness and abnormal heart rhythms. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in critical care needing breathing support or medication for shock.
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I am 18 years old or older.
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I am under continuous heart monitoring.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have ongoing or occasional atrial fibrillation.
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I am currently on dialysis.
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I need injections for magnesium treatment for conditions like pre-eclampsia or asthma.
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I have undergone heart surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RCT Feasibility
Secondary study objectives
Acute Care Outcomes
Hospital Outcomes
Other study objectives
Adverse Events
Functional Outcomes

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium SulfateExperimental Treatment1 Intervention
4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses
Group II: 0.9% NaClPlacebo Group1 Intervention
100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium sulfate
2018
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor
373 Previous Clinical Trials
123,926 Total Patients Enrolled
Southeastern Ontario Academic Medical Organization (SEAMO)UNKNOWN
Stephanie Sibley, MDPrincipal InvestigatorQueen's University

Media Library

Magnesium Sulfate (Electrolyte Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05829317 — Phase 4
Difficult Weaning Research Study Groups: 0.9% NaCl, Magnesium Sulfate
Difficult Weaning Clinical Trial 2023: Magnesium Sulfate Highlights & Side Effects. Trial Name: NCT05829317 — Phase 4
Magnesium Sulfate (Electrolyte Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05829317 — Phase 4
~23 spots leftby Mar 2025
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