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

Coronary Artery Disease Clinical Trial

— POMAF-CS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703349
• Other study ID #: CEHDF 850
• Status: Completed
• Phase: Phase 4
• Start date: November 24, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: April 2020
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 20, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Surgery--Complications

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
• Placebo Oral Tablet
Placebo for Magnesium

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	Time from surgery until discharge of the patient	ranges from 5 to 30 days
Other	Stroke	New onset focal neurological deficit following coronary artery surgery	30 postoperative days
Primary	postoperative atrial fibrillation	New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG	7 postoperative days
Secondary	Ventricular response rate	Average ventricular rate during atrial fibrillation episodes	During the atrial fibrillation episodes
Secondary	Recurrence of atrial fibrillation	Relapse of atrial fibrillation following the initial episode	7 postoperative days