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Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS) (POMAF-CS)

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ClinicalTrials.gov Identifier: NCT03703349
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Samia Madi Jebara, St Joseph University, Beirut, Lebanon

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Coronary Artery Disease Surgery--Complications Drug: Magnesium Sulfate Drug: Placebo Oral Tablet Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
Primary Purpose: Prevention
Official Title: Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperative oral Magnesium
Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention
Drug: Magnesium Sulfate
Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
Other Name: Magnesium

Placebo Comparator: Control
Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention
Drug: Placebo Oral Tablet
Placebo for Magnesium
Other Name: Placebo




Primary Outcome Measures :
  1. postoperative atrial fibrillation [ Time Frame: 7 postoperative days ]
    New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG


Secondary Outcome Measures :
  1. Ventricular response rate [ Time Frame: During the atrial fibrillation episodes ]
    Average ventricular rate during atrial fibrillation episodes

  2. Recurrence of atrial fibrillation [ Time Frame: 7 postoperative days ]
    Relapse of atrial fibrillation following the initial episode


Other Outcome Measures:
  1. Length of hospital stay [ Time Frame: ranges from 5 to 30 days ]
    Time from surgery until discharge of the patient

  2. Stroke [ Time Frame: 30 postoperative days ]
    New onset focal neurological deficit following coronary artery surgery



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03703349


Contacts
Contact: Samia N Madi-Jebara, MD 00961 1 604 000 ext 8938 samiajebara@gmail.com
Contact: Ghassan Sleilaty, MD 00961 1 604 000 ext 7425 ghassan.sleilaty@usj.edu.lb

Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Investigators
Principal Investigator: Samia N Madi-Jebara Saint-Joseph University

Responsible Party: Samia Madi Jebara, Professor, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03703349     History of Changes
Other Study ID Numbers: CEHDF 850
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samia Madi Jebara, St Joseph University, Beirut, Lebanon:
Coronary artery surgery
oral magnesium
atrial fibrillation
Randomized controlled trial

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
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
Tocolytic Agents
Reproductive Control Agents