Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS) (POMAF-CS)
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|ClinicalTrials.gov Identifier: NCT03703349|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Coronary Artery Disease Surgery--Complications||Drug: Magnesium Sulfate Drug: Placebo Oral Tablet||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.|
|Official Title:||Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
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 Name: 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 Name: Placebo
- postoperative atrial fibrillation [ Time Frame: 7 postoperative days ]New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
- Ventricular response rate [ Time Frame: During the atrial fibrillation episodes ]Average ventricular rate during atrial fibrillation episodes
- Recurrence of atrial fibrillation [ Time Frame: 7 postoperative days ]Relapse of atrial fibrillation following the initial episode
- Length of hospital stay [ Time Frame: ranges from 5 to 30 days ]Time from surgery until discharge of the patient
- Stroke [ Time Frame: 30 postoperative days ]New onset focal neurological deficit following coronary artery surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703349
|Contact: Samia N Madi-Jebara, MD||00961 1 604 000 ext firstname.lastname@example.org|
|Contact: Ghassan Sleilaty, MD||00961 1 604 000 ext email@example.com|
|Principal Investigator:||Samia N Madi-Jebara||Saint-Joseph University|