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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Study group) | Active Comparator | 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. |
|
| Group B (Control group) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulphate | Drug | Intravenous Magnesium sulphate followed by oral tablets of Magnesium sulphate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total ICU Length of Stay | Total duration of ICU admission from postoperative transfer to discharge, measured in days | From ICU admission until discharge (assessed up to 30 days) |
| Total Ventilation Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine ,Ain Shams University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15831645 | Background | Miller S, Crystal E, Garfinkle M, Lau C, Lashevsky I, Connolly SJ. Effects of magnesium on atrial fibrillation after cardiac surgery: a meta-analysis. Heart. 2005 May;91(5):618-23. doi: 10.1136/hrt.2004.033811. | |
| 10654548 | Background | Hogue CW Jr, Hyder ML. Atrial fibrillation after cardiac operation: risks, mechanisms, and treatment. Ann Thorac Surg. 2000 Jan;69(1):300-6. doi: 10.1016/s0003-4975(99)01267-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Study Group) | 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. |
| FG001 | Group B (Control Group) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Study Group) | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | 7 days |
|
From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Study Group) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal impairment | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Sarah Elghareeb,lecturer of Anesthesia and ICU | Ain Shams University | +201012434690 | Sarahhamdy@med.asu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2024 | Jul 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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This study is a prospective, randomized controlled trial that will study the postoperative anti-arrhythmic effect of Magnesium Sulfate and clinical outcomes of administration of intravenous Mg Sulfate in patients undergoing open heart surgery.
Randomization will be performed using a computer-generated randomization sequence and allocation concealment to be maintained all through the time of procedure, by using opaque, numbered, and sealed envelopes.
Informed consent will be obtained from each patient before patients' allocation.
Patients will be randomly allocated by computer generated randomization into two groups A and B.
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) and group B will receive 50 cc normal 0.9 % saline via intravenous infusion.
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| Placebo | Drug | Intravenous infusion of Normal saline 0.9 followed by starch oral tablets |
|
mechanical ventilatory support in hours
| 48 hours |
| Number of Participants With New Postoperative Renal Impairment | Count of participants meeting ≥1 criterion:
| 30 days |
| 2566713 | Background | Fuller JA, Adams GG, Buxton B. Atrial fibrillation after coronary artery bypass grafting. Is it a disorder of the elderly? J Thorac Cardiovasc Surg. 1989 Jun;97(6):821-5. |
| BG001 | Group B (Control Group) | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Group B (Control Group) | 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. |
|
|
| Secondary | Total ICU Length of Stay | Total duration of ICU admission from postoperative transfer to discharge, measured in days | Posted | Mean | Standard Deviation | days | From ICU admission until discharge (assessed up to 30 days) |
|
|
|
| Secondary | Total Ventilation Time | mechanical ventilatory support in hours | Posted | Mean | Standard Deviation | hours | 48 hours |
|
|
|
| Secondary | Number of Participants With New Postoperative Renal Impairment | Count of participants meeting ≥1 criterion:
| Posted | Number | participants | 30 days |
|
|
|
| 0 |
| 65 |
| 10 |
| 65 |
| 8 |
| 65 |
| EG001 | Group B (Control Group) | 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. | 0 | 65 | 20 | 65 | 10 | 65 |
| Stroke | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
|
| Reoperation for bleeding | Surgical and medical procedures | MedDRA v26.0 | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |