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

NCT03703349 | Completed Phase 4

• 1 other identifier: CEHDF 850
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Coronary Artery Disease; Surgery--Complications

Keywords

Coronary artery surgery; oral magnesium; atrial fibrillation; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• postoperative atrial fibrillation

  New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG

  7 postoperative days

Secondary Outcomes (2)

• Ventricular response rate

  During the atrial fibrillation episodes

• Recurrence of atrial fibrillation

  7 postoperative days

Other Outcomes (2)

• Length of hospital stay

  ranges from 5 to 30 days

• Stroke

  30 postoperative days

Study Arms (2)

Preoperative oral Magnesium

EXPERIMENTAL

Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention

Drug: Magnesium Sulfate

Control

PLACEBO COMPARATOR

Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention

Drug: Placebo Oral Tablet

Interventions

Magnesium Sulfate DRUG

Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery

Also known as: Magnesium

Preoperative oral Magnesium

Placebo Oral Tablet DRUG

Placebo for Magnesium

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Coronary artery disease
• Planned coronary artery surgery
• signed informed consent

You may not qualify if:

• 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
• nd and 3rd degree atrioventricular bloc
• Renal failure with GFR \< 30 ml/min/1.73 m²

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu de France

Beirut, 166830, Lebanon

Location

Related Publications (1)

• 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.

  PMID: 35451469 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

Magnesium Sulfate; Magnesium

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Metals, Alkaline Earth; Elements; Metals, Light; Metals

Study Officials

• Samia N Madi-Jebara

  Saint-Joseph University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: treatment concealment will be managed by the central pharmacy of the hospital, which will dispense treatment according to the randomization plan.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 11, 2018
• Study Start: November 24, 2018
• Primary Completion: October 20, 2019
• Study Completion: October 20, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

LE (1)