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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
control
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

magnesium

control

Arm Description

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.

100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days

Outcomes

Primary Outcome Measures

Atrial fibrillation
the incidence of postoperative atrial fibrillation

Secondary Outcome Measures

Full Information

First Posted
October 7, 2016
Last Updated
October 7, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02928315
Brief Title
The Effect of Magnesium Therapy to Prevent Post-operative Atrial Fibrillation After Cardiac Surgery in Adults
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
magnesium
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
100 ml of normal saline solution infused intravenously over 4 hours once daily , for 3 days
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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 Measure Information:
Title
Atrial fibrillation
Description
the incidence of postoperative atrial fibrillation
Time Frame
3 post operative days

10. Eligibility

Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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