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The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928315
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Magnesium Sulfate Other: control Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults, Concerning the Perioperative Changes in Serum Electrolytes
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: magnesium
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
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.

Placebo Comparator: control
100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days
Other: control
100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.




Primary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: 3 post operative days ]
    the incidence of postoperative atrial fibrillation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients over 18 years.
  • Left ventricular ejection fraction >0.3,
  • Blood pressure is normal or less than 180/110.
  • ASA ≤ III.
  • Normal liver, pulmonary and renal function,
  • No diabetes or other metabolism disorders,
  • No pulmonary hypertension,
  • No atrial fibrillation in the past, sinus rhythm on preoperative electrocardiogram.

Exclusion Criteria:

  • history of AF,
  • implanted pacemaker,
  • postoperative myocardial infarction,
  • use of left ventricular assist devices
  • Renal failure or on hemodialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928315


Locations
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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Emad Zarief , MD, Lecturer of Anesthesia and critical care Medicine, Assiut University
ClinicalTrials.gov Identifier: NCT02928315    
Other Study ID Numbers: IRB00009907
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents