Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS) (POMAF-CS)
Primary Purpose
Atrial Fibrillation, Coronary Artery Disease, Surgery--Complications
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Adult patients
- Coronary artery disease
- Planned coronary artery surgery
- signed informed consent
Exclusion Criteria:
- Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
- Left ventricular EF < 30%
- Urgent surgery
- Redo surgery
- Permanent preoperative pacemaker
- Preoperative anti arrythmia drugs classes I and III
- Post operative inotrope drugs
- Postoperative bradycardia necessitating electrosystolic pacing
- Preoperative heart rate less than 50 bpm
- documented preoperative dysthryroidism
- 2nd and 3rd degree atrioventricular bloc
- Renal failure with GFR < 30 ml/min/1.73 m²
Sites / Locations
- Hotel Dieu de France
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Preoperative oral Magnesium
Control
Arm Description
Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention
Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
Outcomes
Primary Outcome Measures
postoperative atrial fibrillation
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
Secondary Outcome Measures
Ventricular response rate
Average ventricular rate during atrial fibrillation episodes
Recurrence of atrial fibrillation
Relapse of atrial fibrillation following the initial episode
Full Information
NCT ID
NCT03703349
First Posted
October 9, 2018
Last Updated
April 25, 2020
Sponsor
St Joseph University, Beirut, Lebanon
1. Study Identification
Unique Protocol Identification Number
NCT03703349
Brief Title
Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)
Acronym
POMAF-CS
Official Title
Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 24, 2018 (Actual)
Primary Completion Date
October 20, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.
Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.
Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.
The occurrence of POAF will be studied as a main outcome.
Detailed Description
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.
Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.
Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:
Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Coronary Artery Disease, Surgery--Complications
Keywords
Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to the 2 groups of treatment by blocks of 8. The randomization list will be computer-generated, with no factors for stratification. To reduce predictability of the random sequence, blocking will be made unavailable to those who assign interventions.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative oral Magnesium
Arm Type
Experimental
Arm Description
Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Magnesium
Intervention Description
Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo for Magnesium
Primary Outcome Measure Information:
Title
postoperative atrial fibrillation
Description
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
Time Frame
7 postoperative days
Secondary Outcome Measure Information:
Title
Ventricular response rate
Description
Average ventricular rate during atrial fibrillation episodes
Time Frame
During the atrial fibrillation episodes
Title
Recurrence of atrial fibrillation
Description
Relapse of atrial fibrillation following the initial episode
Time Frame
7 postoperative days
Other Pre-specified Outcome Measures:
Title
Length of hospital stay
Description
Time from surgery until discharge of the patient
Time Frame
ranges from 5 to 30 days
Title
Stroke
Description
New onset focal neurological deficit following coronary artery surgery
Time Frame
30 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients
Coronary artery disease
Planned coronary artery surgery
signed informed consent
Exclusion Criteria:
Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
Left ventricular EF < 30%
Urgent surgery
Redo surgery
Permanent preoperative pacemaker
Preoperative anti arrythmia drugs classes I and III
Post operative inotrope drugs
Postoperative bradycardia necessitating electrosystolic pacing
Preoperative heart rate less than 50 bpm
documented preoperative dysthryroidism
2nd and 3rd degree atrioventricular bloc
Renal failure with GFR < 30 ml/min/1.73 m²
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia N Madi-Jebara
Organizational Affiliation
Saint-Joseph University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de France
City
Beirut
ZIP/Postal Code
166830
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be made available upon request from researchers who need to perform a meta analysis on the subject.
IPD will be sent directly to the requesting party
Citations:
PubMed Identifier
35451469
Citation
Tohme J, Sleilaty G, Jabbour K, Gergess A, Hayek G, Jebara V, Madi-Jebara S. Preoperative oral magnesium loading to prevent postoperative atrial fibrillation following coronary surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac269. doi: 10.1093/ejcts/ezac269.
Results Reference
derived
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Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)
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