An interventional study of Magnesium Sulfate and control in Atrial Fibrillation, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-10.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
It is well known that magnesium sulfate has a membrane stabilizing effect , and broad spectrum anti arrhythmic properties. In this trial, the investigators study its prophylactic effect against atrial fibrillation in postoperative period of cardiac surgery.
One of the most common postoperative complications after cardiac surgery is postoperative atrial fibrillation (AF). It is rarely fatal but it may cause subjective symptoms and result in thromboembolic complications, heart failure, renal insufficiency, and stroke which may prolong hospital stay.
The risk factors of AF include advanced age, transient atrial ischemia, arterial hypertension, dilated atria, male sex, pulmonary hypertension, previous atrial fibrillation and serum electrolyte disorders . On the other hand, there is evidence that cardiopulmonary bypass (CPB) time, duration of aortic cross clamping and the time of surgery, also the type of cardioplegia and the number of constructed grafts do not influence the incidence of AF.
There are only few studies that show the depletion of electrolytes and serum electrolyte concentration changes after cardiac surgery . The role of potassium in pathogenesis of cardiac arrhythmias is well recognized. Low serum potassium level is often found in association with hypomagnesemia and predisposes to atrial fibrillation. Extracellular magnesium is broadly implicated in neuronal control, neuromuscular transmission, and cardiovascular tone. It has been shown that magnesium suppresses arrhythmias after acute myocardial infarction, and there are studies confirming correlation between hypomagnesemia and postoperative atrial fibrillation . The underlying mechanism of these effects is not well understood but most probably involves magnesium interaction with calcium channels within myocytes membrane. Still the role of magnesium in the pathogenesis of AF is not clear yet.
Also, it is not clear if magnesium supplementation is useful for these patients, or it is useful only in hypomagnesemia patients. Hypophosphatemia and its consequences are less investigated in patients after cardiac surgery. Common complications after cardiac surgery are cardiac and respiratory failure, and they are also among the clinical manifestations of hypophosphatemia. Hypophosphatemia could be the cause of prolonged artificial lung ventilation and myocardial dysfunction; also, it may have influence on the incidence of arrhythmias. Anyway, there are no data confirming the arrhythmogenic effect of changes in serum phosphate level.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 40 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
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Five ampules of 500 mg of magnesium sulfate will be dissolved in 100 ml of normal saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
Drug: Magnesium Sulfate
100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days
Other: control
The patients in the study group will receive 10 mmol of magnesium sulphate (2.47 gm). Five ampoules of 500 mg of magnesium sulphate will be dissolved in 100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
Atrial fibrillation
the incidence of postoperative atrial fibrillation
Time frame: 3 post operative days
Plan to share: Yes
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The record gives a start of Aug 2015, a primary completion of Aug 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate