A Phase 3 interventional study of Magnesium sulphate and Placebo in Atrial Fibrillation (AF), Magnesium Sulfate and Post Cardiac Surgery Patients, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
Atrial fibrillation (AF) is a common complication after cardiac surgery. Most studies suggest that the frequency ranges between 25-40%.
Some studies have shown that serum hypomagnesaemia is common after coronary artery bypass grafts (CABG) and other types of cardiac surgery and is associated with postoperative morbidity such as atrial tachyarrhythmia.
The aim of the present study is to investigate the anti-arrhythmic effect of Magnesium Sulfate in prevention of atrial fibrillation post cardiac surgery.
Atrial fibrillation (AF) is a common complication after cardiac surgery. Most studies suggest that the frequency ranges between 25-40%.
Several reports have indicated that postoperative AF is associated with an increased length of in-hospital stay (LOS) and consequently a greater utilization of health care resources.
Postoperative AF is also associated with higher rates of postoperative stroke, compromised cardiac function, and adverse effects from drugs used to prevent AF.
Despite many years of clinical experience and a large amount of investigation, prevention, and treatment of postoperative AF remain controversial. Many questions about the mechanisms and pathophysiology of AF remain unanswered, further contributing to the ambiguity in reaching consensus about appropriate treatment. Increasing patient age, valvular lesion and dilated atrial diameter is generally considered the greatest risk factor for postoperative AF and an aging population suggest that postoperative AF will continue to be a considerable problem in the future.
Magnesium (Mg) is an important intracellular ion with electrophysiological properties. It is essential for optimal metabolic cell function. Mg has proven effective for treating eclampsia, preeclampsia, and torsade's de pointes. Other therapeutic applications such as adjunctive therapy in acute asthma exacerbations, acute coronary syndromes, acute cerebral ischemia, and postoperative pain control are under discussion.
Some studies have shown that serum hypomagnesaemia is common after coronary artery bypass grafts (CABG) and other types of cardiac surgery. and is associated with postoperative morbidity such as atrial tachyarrhythmia.
Some clinical trials have assessed the efficacy of magnesium as a method of intervention to reduce the incidence of postoperative AF. Though this study is a negative one, other studies showed that magnesium sulfate has a body of evidence supporting its anti-arrhythmic effects and safety profile in AF prevention post-surgery.
A Phase III trial is necessary to further validate the efficacy and safety of magnesium sulfate because the previous studies, while promising, have shown varying results and may have methodological limitations such as small sample sizes, lack of rigorous randomization, or not accounting for long-term outcomes. This study aims to provide definitive evidence through a well-powered randomized controlled trial, using more rigorous study designs, thereby filling an important gap in clinical evidence.
The currently considered standard preventive care for AF after cardiac surgery includes the use of beta-blockers, amiodarone, or other antiarrhythmic drugs. These measures can then be contrasted with the magnesium sulfate intervention, highlighting its potential advantages and rationale for testing in this study.
A placebo group is used in this study since magnesium sulfate has shown some benefit in previous studies, the evidence is not definitive. Therefore, a placebo group is necessary to ensure that any observed effects of magnesium sulfate are due to the treatment and not other confounding factors.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 130 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group A will receive 2 gm of Mg Sulfate diluted in 30 cc normal 0.9 % saline via intravenous infusion over 1 hour (1 Mg sulfate ampoule = 10 cc) . On ICU arrival group A will continue receiving 1 gm of Mg sulfate per hour for five hours via continuous IV infusion. After 5 hours, group A will receive 200 mg of Mg sulfate per hour for 19 hours via continuous IV infusion, then oral replacement of mag added 1 gm/8 hours tablet. Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge. Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.
Drug: Magnesium sulphate
After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group B will receive 50 cc normal 0.9 % saline via intravenous infusion over same period. On ICU arrival group B will same volume and rate of normal saline. After 5 hours, group B will receive same fluid volume and rate of normal saline followed by oral inert starch tablets. Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge. Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.
Drug: Placebo
Intravenous Magnesium sulphate followed by oral tablets of Magnesium sulphate
Intravenous infusion of Normal saline 0.9 followed by starch oral tablets
Number of Participants With New Episodes of Atrial Fibrillation
Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).
Time frame: 7 days
Total ICU Length of Stay
Total duration of ICU admission from postoperative transfer to discharge, measured in days
Time frame: From ICU admission until discharge (assessed up to 30 days)
Total Ventilation Time
mechanical ventilatory support in hours
Time frame: 48 hours
Number of Participants With New Postoperative Renal Impairment
Count of participants meeting ≥1 criterion: 1. Postoperative serum creatinine ≥1.8 mg/dL 2. Requirement of renal replacement therapy (hemodialysis, transient, or permanent)
Time frame: 30 days
| Milestone | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Started | 65 | 65 |
| Completed | 65 | 65 |
| Not completed | 0 | 0 |
Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).
| participants | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Number of Participants With New Episodes of Atrial Fibrillation | 12 | 27 |
Total duration of ICU admission from postoperative transfer to discharge, measured in days
| days | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Total ICU Length of Stay | 2.1 ± 0.8 | 3.5 ± 1.2 |
mechanical ventilatory support in hours
| hours | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Total Ventilation Time | 8.4 ± 3.1 | 7.8 ± 2.1 |
Count of participants meeting ≥1 criterion: 1. Postoperative serum creatinine ≥1.8 mg/dL 2. Requirement of renal replacement therapy (hemodialysis, transient, or permanent)
| participants | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Number of Participants With New Postoperative Renal Impairment | 4 | 9 |
Collected over From surgery until hospital discharge, up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (Study Group) | 0/65 (0%) | 10/65 (15.4%) | 8/65 (12.3%) |
| Group B (Control Group) | 0/65 (0%) | 20/65 (30.8%) | 10/65 (15.4%) |
| Event | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| Renal impairmentRenal and urinary disorders | 4/65 | 9/65 |
| Reoperation for bleedingSurgical and medical procedures | 5/65 | 9/65 |
| StrokeNervous system disorders | 1/65 | 2/65 |
| Event | Group A (Study Group) | Group B (Control Group) |
|---|---|---|
| HypotensionCardiac disorders | 8/65 | 10/65 |
| Age, Continuous(years) | Group A (Study Group) | Group B (Control Group) | Total |
|---|---|---|---|
| Mean | 58.1 ± 10.3 | 59.0 ± 9.7 | 58.6 ± 10 |
| Sex: Female, Male(Participants) | Group A (Study Group) | Group B (Control Group) | Total |
|---|---|---|---|
| Female | 20 | 17 | 37 |
| Male | 45 | 48 | 93 |
| Race and Ethnicity Not Collected(Participants) | Group A (Study Group) | Group B (Control Group) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Ain Shams University