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

St Joseph University, Beirut, Lebanon

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Atrial Fibrillation

Surgery--Complications

Treatments

Drug: Placebo Oral Tablet

Drug: Magnesium Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT03703349

CEHDF 850

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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