Magnesium Supplementation for Heart Surgery Complications

Overseen By David A Rosen, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Must not be taking: Anti-arrhythmia medications

Disqualifiers: Renal disease, Pre-existing arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that children not be on anti-arrhythmia medication to participate.

What data supports the effectiveness of the drug Tailored MgSO4 Supplementation for reducing complications after heart surgery?

Research shows that magnesium can help reduce irregular heartbeats (arrhythmias) after heart surgery, which suggests it might be effective in preventing complications when used as a tailored supplement. ^{1 2 3 4 5}

Is magnesium supplementation safe for heart surgery patients?

Research shows that magnesium supplementation, often given as magnesium sulfate, is generally safe for patients undergoing heart surgery. It has been used to help prevent irregular heartbeats after surgery, with studies indicating it is well-tolerated in both adults and children. ^{1 6 7 8 9}

How is the drug Tailored MgSO4 Supplementation unique for heart surgery complications?

Tailored MgSO4 Supplementation is unique because it involves personalized magnesium sulfate dosing to prevent complications like arrhythmias (irregular heartbeats) after heart surgery, which is not a standard approach in current treatments. This method focuses on maintaining optimal magnesium levels to reduce the risk of postoperative heart rhythm issues. ^{1 6 7 9 10}

What is the purpose of this trial?

Lay Summary This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems after surgery. The right amount of magnesium in blood reduces this risk. This study will test the best way to measure magnesium. This will let doctors choose the right dose of MgSO4. MgSO4 is a magnesium supplement. Taking MgSO4 after heart surgery helps children. For each child, it is best to personalize MgSO4 dose. This is based on the amount of magnesium in blood. This study will test two ways of personalizing MgSO4 dose. In the blood, there are two kinds of magnesium. Usually, blood magnesium tests measure both forms together. This does not say anything about active magnesium. This study will measure the two forms separately. Then, MgSO4 will be given based on either the active or whole magnesium. Measuring active magnesium is good. Active magnesium levels change faster than total. That means active magnesium tests may better protect children. Also, active magnesium has more of an impact on heart and kidney function. Focusing on the active form will help these organs stay healthy. To test how well the MgSO4 is working, heart and kidneys will be examined. After surgery, certain harmful heart rhythms can occur. The types and number of harmful rhythms will be studied. Kidney problems can also happen after heart surgery. Kidney health will be studied. To help understand how active magnesium works, further tests will be done. These tests will look for evidence of poor health in the cells that make up the heart, kidney, and blood.

Research Team

David A Rosen, MD

Principal Investigator

West Virginia University

Eligibility Criteria

This trial is for children undergoing heart surgery who may face post-surgery complications like heart and kidney issues. It aims to personalize magnesium supplementation (MgSO4) based on blood levels to improve outcomes.

Inclusion Criteria

My child is having heart surgery with a heart-lung machine.

Exclusion Criteria

My child has kidney disease.

My child is having heart surgery without using a heart-lung machine.

My child has a heart rhythm problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Randomization and preparation for surgery, including baseline magnesium level measurement

1 week

1 visit (in-person)

Intraoperative

MgSO4 administration begins at the intraoperative stage based on randomization to ionized or total magnesium strategy

During surgery

Postoperative Treatment

MgSO4 dosing continues post-surgery with monitoring of magnesium levels and clinical outcomes

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of renal and cardiac function

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Tailored MgSO4 Supplementation

Trial Overview The study tests two methods of measuring magnesium in the blood: ionized (active) and total magnesium, to determine which is better for guiding MgSO4 dosing after pediatric heart surgery.

Participant Groups

Group I: Total magnesium Experimental Treatment 1 Intervention

Magnesium dosing based on total Mg blood level

Group II: ionized Magnesium Active Control 1 Intervention

Magnesium dosing based upon ionized Mg level

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Systemic magnesium to reduce postoperative arrhythmias after coronary artery bypass graft surgery: a meta-analysis of randomized controlled trials. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative atrial tachyarrhythmias in patients undergoing coronary artery bypass graft surgery without cardiopulmonary bypass: a role for intraoperative magnesium supplementation. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Magnesium administration and dysrhythmias after cardiac surgery. A placebo-controlled, double-blind, randomized trial. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Randomised trial on the influence of continuous magnesium infusion on arrhythmias following cardiopulmonary bypass surgery for congenital heart disease. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A beta-blocker, not magnesium, is effective prophylaxis for atrial tachyarrhythmias after coronary artery bypass graft surgery. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Magnesium supplementation during cardiopulmonary bypass to prevent junctional ectopic tachycardia after pediatric cardiac surgery: a randomized controlled study. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Magnesium substitution and postoperative arrhythmias in patients undergoing coronary artery bypass grafting. [2019]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Role of magnesium in preventing post-operative atrial fibrillation after coronary artery bypass surgery. [2014]

9. Australia pubmed.ncbi.nlm.nih.gov

Magnesium sulphate replacement therapy in cardiac surgery patients: A systematic review. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Oral magnesium prophylaxis provides spontaneous resumption of cardiac rhythm in patients undergoing cardiac surgery. [2017]