Atrial Fibrillation, Coronary Artery Disease, Surgery--Complications
Conditions
Keywords
Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial
Brief summary
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
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.
Interventions
DRUGMagnesium Sulfate
Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
DRUGPlacebo Oral Tablet
Placebo for Magnesium
Sponsors
St Joseph University, Beirut, Lebanon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative atrial fibrillation | 7 postoperative days | New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular response rate | During the atrial fibrillation episodes | Average ventricular rate during atrial fibrillation episodes |
| Recurrence of atrial fibrillation | 7 postoperative days | Relapse of atrial fibrillation following the initial episode |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | ranges from 5 to 30 days | Time from surgery until discharge of the patient |
| Stroke | 30 postoperative days | New onset focal neurological deficit following coronary artery surgery |
Countries
Lebanon
Outcome results
None listed