Clinical trial NCT03703349: Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Coronary Artery Disease
Surgery--Complications
Keywords: Coronary artery surgery
oral magnesium
atrial fibrillation
Randomized controlled trial
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative atrial fibrillation
timeFrame: 7 postoperative days
Secondary outcomes:
measure: Ventricular response rate
timeFrame: During the atrial fibrillation episodes
measure: Recurrence of atrial fibrillation
timeFrame: 7 postoperative days
Other outcomes:
measure: Length of hospital stay
timeFrame: ranges from 5 to 30 days
measure: Stroke
timeFrame: 30 postoperative days
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
Study officials:
affiliation: Saint-Joseph University
name: Samia N Madi-Jebara
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.