Back to resultsMagnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients (ATOMIC)
Primary Purpose
Critical Illness, New Onset Atrial Fibrillation
Status
Not yet recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Magnesium sulfate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring Prophylaxis, Prevention
Eligibility Criteria
Inclusion Criteria: Age ≥18 years 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 Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent) Receiving continuous cardiac monitoring. Exclusion Criteria: >12 hours from ICU admission Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation Unlikely to survive >24 hours or palliative patients Cardiac surgery patients Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma) Transfer from another ICU Patients receiving dialysis Positive pregnancy test Previously enrolled in this trial Treating physician refuses enrollment
Sites / Locations
- Kingston Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium Sulfate
0.9% NaCl
Arm Description
4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses
100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses
Outcomes
Primary Outcome Measures
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)
RCT Feasibility
2) Recruitment rate of ≥ 6 patients/month (2 patient/month/ICU)
RCT Feasibility
3) CardioSTAT tolerance and use ≥ 90% (defined appropriate placement, uninterrupted wear, and returned monitors)
RCT Feasibility
4) In-hospital MRI and echocardiogram procurement ≥ 90% for patients alive and able to be transported.
Secondary Outcome Measures
Acute Care Outcomes
Total number of patients developing NOAF within 14 days of enrolment
Acute Care Outcomes
Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants
Acute Care Outcomes
bleeding events
Acute Care Outcomes
thromboembolic events
Acute Care Outcomes
persistent organ disfunction
Acute Care Outcomes
mortality
Hospital Outcomes
Development of renal failure requiring dialysis
Hospital Outcomes
ICU length of stay
Hospital Outcomes
hospital length of stay
Full Information
NCT ID
NCT05829317
First Posted
March 15, 2023
Last Updated
April 12, 2023
Sponsor
Queen's University
Collaborators
Southeastern Ontario Academic Medical Organization (SEAMO)
1. Study Identification
Unique Protocol Identification Number
NCT05829317
Brief Title
Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
Acronym
ATOMIC
Official Title
Parenteral Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients - a Pilot Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Southeastern Ontario Academic Medical Organization (SEAMO)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, New Onset Atrial Fibrillation
Keywords
Prophylaxis, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium Sulfate
Arm Type
Experimental
Arm Description
4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses
Arm Title
0.9% NaCl
Arm Type
Placebo Comparator
Arm Description
100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
Intravenous Magnesium sulfate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% NaCl
Primary Outcome Measure Information:
Title
RCT Feasibility
Description
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)
Time Frame
90 days
Title
RCT Feasibility
Description
2) Recruitment rate of ≥ 6 patients/month (2 patient/month/ICU)
Time Frame
90 days
Title
RCT Feasibility
Description
3) CardioSTAT tolerance and use ≥ 90% (defined appropriate placement, uninterrupted wear, and returned monitors)
Time Frame
90 days
Title
RCT Feasibility
Description
4) In-hospital MRI and echocardiogram procurement ≥ 90% for patients alive and able to be transported.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Acute Care Outcomes
Description
Total number of patients developing NOAF within 14 days of enrolment
Time Frame
28 days
Title
Acute Care Outcomes
Description
Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants
Time Frame
28 days
Title
Acute Care Outcomes
Description
bleeding events
Time Frame
28 days
Title
Acute Care Outcomes
Description
thromboembolic events
Time Frame
28 days
Title
Acute Care Outcomes
Description
persistent organ disfunction
Time Frame
28 days
Title
Acute Care Outcomes
Description
mortality
Time Frame
28 days
Title
Hospital Outcomes
Description
Development of renal failure requiring dialysis
Time Frame
28 days
Title
Hospital Outcomes
Description
ICU length of stay
Time Frame
28 days
Title
Hospital Outcomes
Description
hospital length of stay
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse patch reactions (skin irritation)
Time Frame
90 days
Title
Adverse Events
Description
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)
Time Frame
90 days
Title
Adverse Events
Description
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)
Time Frame
90 days
Title
Functional Outcomes
Description
Clinical Frailty Score
Time Frame
365 days
Title
Functional Outcomes
Description
EuroQoL EQ-5D
Time Frame
365 days
Title
Functional Outcomes
Description
death after discharge
Time Frame
365 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
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 Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent)
Receiving continuous cardiac monitoring.
Exclusion Criteria:
>12 hours from ICU admission
Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation
Unlikely to survive >24 hours or palliative patients
Cardiac surgery patients
Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
Transfer from another ICU
Patients receiving dialysis
Positive pregnancy test
Previously enrolled in this trial
Treating physician refuses enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda Hunt
Phone
613 549 6666
Ext
3190
Email
miranda.hunt@kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sibley, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston Health Sciences Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Hunt
Phone
613 549 9999
Ext
3190
Email
miranda.hunt@kingstonhsc.ca
First Name & Middle Initial & Last Name & Degree
Stephanie Sibley, MD
12. IPD Sharing Statement
Learn more about this trial
Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients
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