A Phase 4 interventional study of Magnesium Sulfate and Placebo Oral Tablet in Atrial Fibrillation, Coronary Artery Disease and Surgery--Complications, sponsored by St Joseph University, Beirut, Lebanon. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by St Joseph University, Beirut, Lebanon · Phase 4, Interventional, and Prevention
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.
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:
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 200 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →St Joseph University, Beirut, Lebanon is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention
Drug: Magnesium Sulfate
Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
Drug: Placebo Oral Tablet
Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
Also known as: Magnesium
Placebo for Magnesium
Also known as: Placebo
postoperative atrial fibrillation
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
Time frame: 7 postoperative days
Ventricular response rate
Average ventricular rate during atrial fibrillation episodes
Time frame: During the atrial fibrillation episodes
Recurrence of atrial fibrillation
Relapse of atrial fibrillation following the initial episode
Time frame: 7 postoperative days
Length of hospital stay
Time from surgery until discharge of the patient
Time frame: ranges from 5 to 30 days
Stroke
New onset focal neurological deficit following coronary artery surgery
Time frame: 30 postoperative days
Plan to share: Undecided — IPD will be made available upon request from researchers who need to perform a meta analysis on the subject. IPD will be sent directly to the requesting party
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate
St Joseph University, Beirut, Lebanon