Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)

Study Overview
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Brief Summary
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Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied. 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery. The occurrence of POAF will be studied as a main outcome.

Detailed Description
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Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization. Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied. The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF. Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups: Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery. Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery. The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.

Official Title
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Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial

Conditions
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Atrial Fibrillation, Coronary Artery Disease, Surgery--Complications

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Coronary artery disease Planned coronary artery surgery signed informed consent Exclusion Criteria: Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic Left ventricular EF < 30% Urgent surgery Redo surgery Permanent preoperative pacemaker Preoperative anti arrythmia drugs classes I and III Post operative inotrope drugs Postoperative bradycardia necessitating electrosystolic pacing Preoperative heart rate less than 50 bpm documented preoperative dysthryroidism 2nd and 3rd degree atrioventricular bloc Renal failure with GFR < 30 ml/min/1.73 m²

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be assigned to the 2 groups of treatment by blocks of 8. The randomization list will be computer-generated, with no factors for stratification. To reduce predictability of the random sequence, blocking will be made unavailable to those who assign interventions.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative oral Magnesium<br>Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention | Drug: Magnesium Sulfate<br>* Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery<br>* Other names: Magnesium;|
| Placebo Comparator: Control<br>Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention | Drug: Placebo Oral Tablet<br>* Placebo for Magnesium<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative atrial fibrillation | New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG | 7 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular response rate | Average ventricular rate during atrial fibrillation episodes | During the atrial fibrillation episodes | 
| Recurrence of atrial fibrillation | Relapse of atrial fibrillation following the initial episode | 7 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial