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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05829317
Other study ID # ATOMIC
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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