Evaluation of the Role of Magnesium in Prevention of AF Post Cardiac Surgery

NCT06675500 | Completed Phase 3 Results DMC

• 1 other identifier: FMASU R255/2024
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is a common complication after cardiac surgery. Most studies suggest that the frequency ranges between 25-40%. Some studies have shown that serum hypomagnesaemia is common after coronary artery bypass grafts (CABG) and other types of cardiac surgery and is associated with postoperative morbidity such as atrial tachyarrhythmia. The aim of the present study is to investigate the anti-arrhythmic effect of Magnesium Sulfate in prevention of atrial fibrillation post cardiac surgery.

Conditions

Atrial Fibrillation (AF); Magnesium Sulfate; Post Cardiac Surgery Patients

Keywords

magnesium sulphate; post cardiac surgery arrhythmia; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With New Episodes of Atrial Fibrillation

  Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).

  7 days

Secondary Outcomes (3)

• Total ICU Length of Stay

  From ICU admission until discharge (assessed up to 30 days)

• Total Ventilation Time

  48 hours

• Number of Participants With New Postoperative Renal Impairment

  30 days

Study Arms (2)

Group A (Study group)

ACTIVE COMPARATOR

After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group A will receive 2 gm of Mg Sulfate diluted in 30 cc normal 0.9 % saline via intravenous infusion over 1 hour (1 Mg sulfate ampoule = 10 cc) . On ICU arrival group A will continue receiving 1 gm of Mg sulfate per hour for five hours via continuous IV infusion. After 5 hours, group A will receive 200 mg of Mg sulfate per hour for 19 hours via continuous IV infusion, then oral replacement of mag added 1 gm/8 hours tablet. Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge. Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.

Drug: Magnesium sulphate

Group B (Control group)

PLACEBO COMPARATOR

After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group B will receive 50 cc normal 0.9 % saline via intravenous infusion over same period. On ICU arrival group B will same volume and rate of normal saline. After 5 hours, group B will receive same fluid volume and rate of normal saline followed by oral inert starch tablets. Total time of Mg/placebo infusion is 24 hours, and oral tablets for 1 week just before hospital discharge. Total serum Magnesium level will be measured immediately post weaning of cardiopulmonary bypass, on ICU arrival, after 24 and 48 hours.

Drug: Placebo

Interventions

Magnesium sulphate DRUG

Intravenous Magnesium sulphate followed by oral tablets of Magnesium sulphate

Group A (Study group)

Placebo DRUG

Intravenous infusion of Normal saline 0.9 followed by starch oral tablets

Group B (Control group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective open heart surgeries for coronary bypass grafting CABG,valvular lesion single or multiple replacement, combined CABG and valvular; with EF in preoperative echo is more than or equal 40%

You may not qualify if:

• Patients refuse to give informed consent.
• Emergency open heart surgeries
• Redo cases.
• Patients with preoperative serum creatinine level ≥ 1.8 mg/dL
• Patients with reduced intra/post operative urine output ≤ 1 ml/kg/hour.
• Patients with Chronic Kidney disease, Renal failure on dialysis
• Patients with rhythm defects as proved by ECG before administration of Mg/Placebo.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine ,Ain Shams University

Cairo, Egypt

Location

Related Publications (3)

• Miller S, Crystal E, Garfinkle M, Lau C, Lashevsky I, Connolly SJ. Effects of magnesium on atrial fibrillation after cardiac surgery: a meta-analysis. Heart. 2005 May;91(5):618-23. doi: 10.1136/hrt.2004.033811.

  PMID: 15831645 BACKGROUND

• Hogue CW Jr, Hyder ML. Atrial fibrillation after cardiac operation: risks, mechanisms, and treatment. Ann Thorac Surg. 2000 Jan;69(1):300-6. doi: 10.1016/s0003-4975(99)01267-9.

  PMID: 10654548 BACKGROUND

• Fuller JA, Adams GG, Buxton B. Atrial fibrillation after coronary artery bypass grafting. Is it a disorder of the elderly? J Thorac Cardiovasc Surg. 1989 Jun;97(6):821-5.

  PMID: 2566713 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr.Sarah Elghareeb,lecturer of Anesthesia and ICU
• Organization: Ain Shams University

Sarahhamdy@med.asu.edu.eg

+201012434690

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia, Intensive Care and Pain management

Model Details: This study is a prospective, randomized controlled trial that will study the postoperative anti-arrhythmic effect of Magnesium Sulfate and clinical outcomes of administration of intravenous Mg Sulfate in patients undergoing open heart surgery. Randomization will be performed using a computer-generated randomization sequence and allocation concealment to be maintained all through the time of procedure, by using opaque, numbered, and sealed envelopes. Informed consent will be obtained from each patient before patients' allocation. Patients will be randomly allocated by computer generated randomization into two groups A and B. After completion of surgical procedure and successful weaning off Cardiopulmonary bypass the patients will be divided into two groups group A will receive 2 gm of Mg Sulfate diluted in 30 cc normal 0.9 % saline via intravenous infusion over 1 hour (1 Mg sulfate ampoule = 10 cc) and group B will receive 50 cc normal 0.9 % saline via intravenous infusion.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-08

Locations

EG (1)