Trial Outcomes & Findings for Evaluation of the Role of Magnesium in Prevention of AF Post Cardiac Surgery (NCT NCT06675500)
NCT ID: NCT06675500
Last Updated: 2025-08-17
Results Overview
Count of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
7 days
Results posted on
2025-08-17
Participant Flow
Participant milestones
| Measure |
Group A (Study Group)
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.
|
Group B (Control Group)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
65
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A (Study Group)
n=65 Participants
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.
|
Group B (Control Group)
n=65 Participants
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.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 10.3 • n=65 Participants
|
59.0 years
STANDARD_DEVIATION 9.7 • n=65 Participants
|
58.6 years
STANDARD_DEVIATION 10 • n=130 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=65 Participants
|
17 Participants
n=65 Participants
|
37 Participants
n=130 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=65 Participants
|
48 Participants
n=65 Participants
|
93 Participants
n=130 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 7 daysCount of participants developing atrial fibrillation (AF) (episode \>30 seconds) confirmed by 12-lead ECG or continuous telemetry during hospitalization (≤7 days).
Outcome measures
| Measure |
Group A (Study Group)
n=65 Participants
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.
|
Group B (Control Group)
n=65 Participants
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.
|
|---|---|---|
|
Number of Participants With New Episodes of Atrial Fibrillation
|
12 participants
|
27 participants
|
SECONDARY outcome
Timeframe: From ICU admission until discharge (assessed up to 30 days)Total duration of ICU admission from postoperative transfer to discharge, measured in days
Outcome measures
| Measure |
Group A (Study Group)
n=65 Participants
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.
|
Group B (Control Group)
n=65 Participants
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.
|
|---|---|---|
|
Total ICU Length of Stay
|
2.1 days
Standard Deviation 0.8
|
3.5 days
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 48 hoursmechanical ventilatory support in hours
Outcome measures
| Measure |
Group A (Study Group)
n=65 Participants
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.
|
Group B (Control Group)
n=65 Participants
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.
|
|---|---|---|
|
Total Ventilation Time
|
8.4 hours
Standard Deviation 3.1
|
7.8 hours
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 30 daysCount of participants meeting ≥1 criterion: 1. Postoperative serum creatinine ≥1.8 mg/dL 2. Requirement of renal replacement therapy (hemodialysis, transient, or permanent)
Outcome measures
| Measure |
Group A (Study Group)
n=65 Participants
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.
|
Group B (Control Group)
n=65 Participants
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.
|
|---|---|---|
|
Number of Participants With New Postoperative Renal Impairment
|
4 participants
|
9 participants
|
Adverse Events
Group A (Study Group)
Serious events: 10 serious events
Other events: 8 other events
Deaths: 0 deaths
Group B (Control Group)
Serious events: 20 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (Study Group)
n=65 participants at risk
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.
|
Group B (Control Group)
n=65 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Renal impairment
|
6.2%
4/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
13.8%
9/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
|
Nervous system disorders
Stroke
|
1.5%
1/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
3.1%
2/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
|
Surgical and medical procedures
Reoperation for bleeding
|
7.7%
5/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
13.8%
9/65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
Other adverse events
| Measure |
Group A (Study Group)
n=65 participants at risk
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.
|
Group B (Control Group)
n=65 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
12.3%
8/65 • Number of events 65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
15.4%
10/65 • Number of events 65 • From surgery until hospital discharge, up to 30 days
Adverse events were systematically assessed from surgery until hospital discharge (up to 30 days) using clinical exams, lab tests (creatinine, electrolytes), telemetry, and intervention records. Events were coded using MedDRA v26.0. Note: All participants were monitored for adverse events.
|
Additional Information
Dr.Sarah Elghareeb,lecturer of Anesthesia and ICU
Ain Shams University
Phone: +201012434690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place