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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

ATOMIC 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.Check my eligibility

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.See study design

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.

ATOMIC Trial 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.

ATOMIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

RCT Feasibility

Secondary outcome measures

Acute Care Outcomes

Hospital Outcomes

Other outcome measures

Adverse Events

Functional Outcomes

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510

30%

Pain with injection of propofol

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine/Magnesium

Control

Lidocaine

Magnesium

ATOMIC 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

~1630

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Queen's UniversityLead Sponsor

366 Previous Clinical Trials

121,597 Total Patients Enrolled

2 Trials studying Atrial Fibrillation

328 Patients Enrolled for Atrial Fibrillation

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

Atrial Fibrillation Research Study Groups: 0.9% NaCl, Magnesium Sulfate

Atrial Fibrillation 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental can Magnesium Sulfate be to one's health?

"The safety of Magnesium Sulfate is assessed to be a 3 on the scale of 1-3 due to it being a Phase 4 trial, indicating that this particular treatment has been given official approval."

Answered by AI

Are there still opportunities to join this research experiment?

"According to the details posted on clinicaltrials.gov, this trial is no longer actively recruiting patients; however, it was initially announced and updated in May 1st 2023 and April 12th 2023 respectively. As an alternative 658 other trials are presently seeking participants for their research endeavours."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients

Dr. Stephanie Sibley 2023. "Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05829317.