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Completed

NCT Number: NCT03703349

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

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

Other names: Magnesium

Placebo oral tablet

Drug

Placebo for Magnesium

Other names: Placebo

Primary outcomes

  1. postoperative atrial fibrillation

    Time frame: 7 postoperative days

    New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG

Secondary outcomes

  1. Ventricular response rate

    Time frame: During the atrial fibrillation episodes

    Average ventricular rate during atrial fibrillation episodes

  2. Recurrence of atrial fibrillation

    Time frame: 7 postoperative days

    Relapse of atrial fibrillation following the initial episode

Other outcomes

  1. Length of hospital stay

    Time frame: ranges from 5 to 30 days

    Time from surgery until discharge of the patient

  2. Stroke

    Time frame: 30 postoperative days

    New onset focal neurological deficit following coronary artery surgery

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

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

Acronym: POMAF-CS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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