Clinical trial NCT05829317: Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
Official title: Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Critical Illness
New Onset Atrial Fibrillation
Keywords: Prophylaxis
Prevention
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Southeastern Ontario Academic Medical Organization (SEAMO)
First posted: 2023-04-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Admitted to a critical care unit with EITHER:

   1. Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration \>24 hours AND/OR
   2. 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 Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent)
3. Receiving continuous cardiac monitoring.

Exclusion Criteria:

1. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) 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 nasal canula, invasive mechanical ventilation or ionotropic support) for \>18h hours

Primary outcomes:
measure: RCT Feasibility
timeFrame: 90 days
measure: RCT Feasibility
timeFrame: 90 days
measure: RCT Feasibility
timeFrame: 90 days
Secondary outcomes:
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Acute Care Outcomes
timeFrame: 28 days
measure: Hospital Outcomes
timeFrame: 28 days
measure: Hospital Outcomes
timeFrame: 28 days
measure: Hospital Outcomes
timeFrame: 28 days
Other outcomes:
measure: Adverse Events
timeFrame: 90 days
measure: Adverse Events
timeFrame: 90 days
measure: Adverse Events
timeFrame: 90 days
measure: Functional Outcomes
timeFrame: 365 days
measure: Functional Outcomes
timeFrame: 365 days
measure: Functional Outcomes
timeFrame: 365 days
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Stephanie Sibley, MD
role: PRINCIPAL_INVESTIGATOR
References: