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

Critical Illness Clinical Trial

— ATOMIC  

Official title:

Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829317
• Other study ID #: ATOMIC
• Status: Recruiting
• Phase: Phase 4
• Start date: August 20, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: Miranda Hunt
• Phone: 613 549 6666
• Email: miranda.hunt[@]kingstonhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. >12 hours from ICU admission

2. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation

3. Unlikely to survive >24 hours or palliative patients

4. Cardiac surgery patients

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

6. Transfer from another ICU

7. Patients receiving dialysis

8. Positive pregnancy test

9. Previously enrolled in this trial

10. Treating physician refuses enrollment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Critical Illness
• New Onset Atrial Fibrillation

Intervention

Drug:
• Magnesium sulfate
Intravenous Magnesium sulfate
• Placebo
0.9% NaCl

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Southeastern Ontario Academic Medical Organization (SEAMO)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse patch reactions (skin irritation)	90 days
Other	Adverse Events	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)	90 days
Other	Adverse Events	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)	90 days
Other	Functional Outcomes	Clinical Frailty Score	365 days
Other	Functional Outcomes	EuroQoL EQ-5D	365 days
Other	Functional Outcomes	death after discharge	365 days
Primary	RCT Feasibility	1) Protocol adherence = 90% (We define protocol adherence as administration of first dose of study drug within 12 hours starting supported ventilation or vasoactive medications, delivery of all additional doses of study drugs for the following 4 days in patients who do not meet any stopping criteria, including patients transferred to the ward)	90 days
Primary	RCT Feasibility	2) Recruitment rate of = 6 patients/month (2 patient/month/ICU)	90 days
Primary	RCT Feasibility	3) CardioSTAT tolerance and use = 90% (defined appropriate placement, uninterrupted wear, and returned monitors)	90 days
Secondary	Acute Care Outcomes	Total number of patients developing NOAF within 14 days of enrolment	28 days
Secondary	Acute Care Outcomes	Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants	28 days
Secondary	Acute Care Outcomes	bleeding events	28 days
Secondary	Acute Care Outcomes	thromboembolic events	28 days
Secondary	Acute Care Outcomes	persistent organ disfunction	28 days
Secondary	Acute Care Outcomes	mortality	28 days
Secondary	Hospital Outcomes	Development of renal failure requiring dialysis	28 days
Secondary	Hospital Outcomes	ICU length of stay	28 days
Secondary	Hospital Outcomes	hospital length of stay	28 days