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

Last updated: November 12, 2024
Sponsor: Dr. Stephanie Sibley
Overall Status: Active - Recruiting

Phase

4

Condition

Arrhythmia

Cardiac Disease

Dysrhythmia

Treatment

Magnesium sulfate

Placebo

Clinical Study ID

NCT05829317
ATOMIC
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Admitted to a critical care unit with EITHER:

  3. Non-invasive ventilation (including high flow nasal canula) or invasivemechanical ventilation with an expected duration >24 hours AND/OR

  4. Vasopressor or ionotropic support for shock of any etiology. Shock is definedby the need for one of the following vasopressors/inotropes: Dopamine Dobutamine Norepinephrine Epinephrine Ephedirine Milrinone at any dose (ifused in conjunction with another agent) Vasopressin (if used in conjunction withanother agent)

  5. Receiving continuous cardiac monitoring.

Exclusion

Exclusion Criteria:

  1. Active atrial fibrillation prior to randomization or pre-existing (permanent orparoxysmal) atrial fibrillation

  2. Unlikely to survive >24 hours or palliative patients

  3. Cardiac surgery patients

  4. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)

  5. Patients receiving dialysis

  6. Positive pregnancy test

  7. Previously enrolled in this trial

  8. Treating physician refuses enrollment

  9. Receiving ICU intervention (Non-invasive ventilation including High flow nasalcanula, invasive mechanical ventilation or ionotropic support) for >18h hours

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Magnesium sulfate
Phase: 4
Study Start date:
August 20, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L2V7
    Canada

    Active - Recruiting

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