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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Atrial Fibrillation; Surgery--Complications
• Intervention / Treatment: Drug: Magnesium Sulfate; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 166830
    • Hotel Dieu de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative oral Magnesium; Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention	Drug: Magnesium 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; Other Names: Magnesium
Placebo Comparator: Control; Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention	Drug: Placebo Oral Tablet; Placebo for Magnesium; Other Names: Placebo

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Time from surgery until discharge of the patient	ranges from 5 to 30 days
Stroke	New onset focal neurological deficit following coronary artery surgery	30 postoperative days

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Investigators: Principal Investigator: Samia N Madi-Jebara, Saint-Joseph University

Publications and helpful links

General Publications

• Tohme J, Sleilaty G, Jabbour K, Gergess A, Hayek G, Jebara V, Madi-Jebara S. Preoperative oral magnesium loading to prevent postoperative atrial fibrillation following coronary surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac269. doi: 10.1093/ejcts/ezac269.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2018
• Primary Completion (Actual): October 20, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; atrial fibrillation; Coronary artery surgery; oral magnesium
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: CEHDF 850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

IPD will be made available upon request from researchers who need to perform a meta analysis on the subject.

IPD will be sent directly to the requesting party

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No