Atrial Fibrillation (AF), Magnesium Sulfate, Post Cardiac Surgery Patients
Conditions
Keywords
magnesium sulphate, post cardiac surgery arrhythmia, atrial fibrillation
Brief summary
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.
Detailed description
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.
Interventions
DRUGMagnesium sulphate
Intravenous Magnesium sulphate followed by oral tablets of Magnesium sulphate
DRUGPlacebo
Intravenous infusion of Normal saline 0.9 followed by starch oral tablets
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Elective open heart surgeries for coronary bypass grafting CABG,valvular lesion single or multiple replacement, combined CABG and valvular; with EF in preoperative echo is more than or equal 40%
Exclusion criteria
* Patients refuse to give informed consent. * Emergency open heart surgeries * Redo cases. * Patients with preoperative serum creatinine level ≥ 1.8 mg/dL * Patients with reduced intra/post operative urine output ≤ 1 ml/kg/hour. * Patients with Chronic Kidney disease, Renal failure on dialysis * Patients with rhythm defects as proved by ECG before administration of Mg/Placebo.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With New Episodes of Atrial Fibrillation | 7 days | Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total ICU Length of Stay | From ICU admission until discharge (assessed up to 30 days) | Total duration of ICU admission from postoperative transfer to discharge, measured in days |
| Total Ventilation Time | 48 hours | mechanical ventilatory support in hours |
| Number of Participants With New Postoperative Renal Impairment | 30 days | Count of participants meeting ≥1 criterion: 1. Postoperative serum creatinine ≥1.8 mg/dL 2. Requirement of renal replacement therapy (hemodialysis, transient, or permanent) |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 65 |
| Total | 130 |
Baseline characteristics
| Characteristic | Group A (Study Group) | Group B (Control Group) | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 10.3 | 59.0 years STANDARD_DEVIATION 9.7 | 58.6 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 17 Participants | 37 Participants |
| Sex: Female, Male Male | 45 Participants | 48 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 8 / 65 | 10 / 65 |
| serious Total, serious adverse events | 10 / 65 | 20 / 65 |
Outcome results
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).
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Study Group) | Number of Participants With New Episodes of Atrial Fibrillation | 12 participants |
| Group B (Control Group) | Number of Participants With New Episodes of Atrial Fibrillation | 27 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (Study Group) | Number of Participants With New Postoperative Renal Impairment | 4 participants |
| Group B (Control Group) | Number of Participants With New Postoperative Renal Impairment | 9 participants |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Study Group) | Total ICU Length of Stay | 2.1 days | Standard Deviation 0.8 |
| Group B (Control Group) | Total ICU Length of Stay | 3.5 days | Standard Deviation 1.2 |
Secondary
Total Ventilation Time
mechanical ventilatory support in hours
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (Study Group) | Total Ventilation Time | 8.4 hours | Standard Deviation 3.1 |
| Group B (Control Group) | Total Ventilation Time | 7.8 hours | Standard Deviation 2.1 |