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

Phase 4

Completed

• Conditions: Surgery--Complications; Coronary Artery Disease; Atrial Fibrillation
• Interventions: Drug: Placebo Oral Tablet; Drug: Magnesium Sulfate

• Registration Number: NCT03703349
• Lead Sponsor: St Joseph University, Beirut, Lebanon

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.

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-11
• Study Start: 2018-11-24
• Primary Completion: 2019-10-20
• Study Completion: 2019-10-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo Oral Tablet	Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
Preoperative oral Magnesium	Magnesium Sulfate	Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention

Primary Outcome Measures

Name	Time	Method
postoperative atrial fibrillation	7 postoperative days	New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hotel Dieu de France; 🇱🇧 Beirut, Lebanon