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| Name | Class |
|---|---|
| Southeastern Ontario Academic Medical Organization (SEAMO) | UNKNOWN |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Experimental | 4g Magnesium sulfate (100mL) BID, given intravenously over 2 hours, for a total of 10 doses |
|
| 0.9% NaCl | Placebo Comparator | 100mL 0.9% NaCl BID, given intravenously over 2 hours, for a total of 10 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate | Drug | Intravenous Magnesium sulfate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| RCT Feasibility | To assess feasibility of patient recruitment, randomization procedures, intervention and data collection and measure protocol adherence. Protocol adherence ≥ 90% (We define protocol adherence as administration of first dose of study drug within 18 hours (+1hr window) of 1st ICU intervention (life sustaining therapy) delivery of all additional | 90 days |
| RCT Feasibility | Recruitment rate of ≥ 2 patients/month/ICU | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Equipoise and Feasibility | Physician willingness to recruit patients in the setting of existing electrolyte replacement protocols; effectiveness of blinding; proportion of patients who meet eligibility criteria of those admitted to ICU; proportion of eligible patients for whom consent is obtained; proportion of patients who re-consent when they regain capacity for those randomized under the deferred consent model; proportion of patients lost to follow-up; time for research personnel to complete study related tasks. |
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Inclusion Criteria
Age ≥18 years;
Admitted to an ICU with one or more of the following:
Continuous cardiac monitoring.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miranda Hunt | Contact | 613 549 6666 | 3190 | miranda.hunt@kingstonhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Sibley, MD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Not yet recruiting | Hamilton | Ontario | L8N 1Y3 | Canada |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Placebo |
| Drug |
0.9% NaCl |
|
| 365 days |
| Acute Care Outcomes | Total number of patients developing AF within 28 days of enrolment (AF will be defined as at least 30 seconds of NOAF detected by cardiac monitoring or ECG); Use of rate and rhythm controlling agents, vasoactive agents, diuretics, steroids, anticoagulants, bleeding events, thromboembolic events (as defined in the 2018 Canadian Stroke Best Practices Guideline1; these will be adjudicated by a neurologist blinded to study groups), persistent organ dysfunction, mortality | 28 days |
| Hospital Outcomes | Days alive and ventilator free, ICU length of stay, and hospital length of stay. | 28 days |
| Adverse Events | Adverse drug reactions including 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); 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) while the study drug is being infused. | 28 days |
| Functional Outcomes | EQ-5D score, death after discharge. | 365 days |
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L2V7 | Canada |
|
| The Ottawa Hospital - General Campus | Not yet recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| The Ottawa Hospital - Civic Campus | Not yet recruiting | Ottawa | Ontario | K1Y 4E9 | Canada |
|
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |