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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-24

Study Completion Date

2019-10-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation Coronary Artery Disease Surgery--Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.

Study Groups

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Preoperative oral Magnesium

Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery

Control

Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo for Magnesium

Interventions

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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

Intervention Type DRUG

Placebo Oral Tablet

Placebo for Magnesium

Intervention Type DRUG

Other Intervention Names

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Magnesium Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No