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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to measure magnesium in children's blood after heart surgery. By doing so, doctors can provide the right amount of magnesium supplement (MgSO4) to help prevent heart and kidney problems. The trial will test two methods: one using the total magnesium level and the other using the active magnesium level, which may offer better protection. Children eligible for this trial need heart surgery with a heart-lung machine (cardiopulmonary bypass) and must not have kidney disease or heart rhythm issues. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve post-surgery care for children.

Will I have to stop taking my current medications?

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

What prior data suggests that these methods of measuring magnesium are safe for children after heart surgery?

Research has shown that magnesium supplements, often given as magnesium sulfate (MgSO4), are generally safe for individuals undergoing heart surgery. Studies have found that magnesium sulfate can lower the risk of heart rhythm problems post-surgery, making it an effective way to enhance recovery.

One study found that using magnesium sulfate to reduce post-surgery complications is both cost-effective and safe, offering a beneficial option for patient recovery.

Overall, magnesium sulfate is well-tolerated, with most individuals not experiencing serious side effects when included in their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Magnesium supplementation for heart surgery complications is unique because it tailors the dosage based on specific magnesium levels in the blood. Unlike traditional approaches that might not consider individual variations, this method uses ionized magnesium and total magnesium levels to personalize treatment. Researchers are excited about this approach because it could lead to more precise and effective management of post-surgery complications, potentially improving recovery times and outcomes for patients.

What evidence suggests that this trial's treatments could be effective for heart surgery complications?

Research has shown that magnesium supplements after heart surgery can reduce complications like irregular heartbeats. One study found that magnesium lowered the risk of certain irregular heart rhythms by 23% and atrial fibrillation by 29%. Another study showed that only 2% of patients who received magnesium developed atrial fibrillation, compared to those who did not. In this trial, participants will receive magnesium dosing based on either ionized magnesium levels or total magnesium blood levels. Adjusting magnesium doses based on individual needs might better protect heart and kidney functions because it works faster. This method could help maintain heart and kidney health after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

David A Rosen, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-heart-diseases-7-2024-20a47

Magnesium Supplementation for Heart Surgery ... Tailored MgSO4 Supplementation is unique because it involves personalized magnesium sulfate dosing to prevent complications like arrhythmias (irregular ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324752/

The Effect of Continuous Magnesium Infusion to Prevent ... An infusion of magnesium rather than a bolus dose of magnesium is probably best suited to prevent this common complication after cardiac surgery ...

3. cureus.com cureus.com/articles/311654-the-connection-between-magnesium-and-heart-health-understanding-its-impact-on-cardiovascular-wellness.pdf

The Connection Between Magnesium and Heart Health In the group that was administered magnesium, atrial fibrillation after surgery affected two patients (2%), whereas in the control group, it.

4. researchgate.net researchgate.net/publication/326044038_Evaluating_the_effect_of_magnesium_supplementation_and_cardiac_arrhythmias_after_acute_coronary_syndrome_A_systematic_review_and_meta-analysis

(PDF) Evaluating the effect of magnesium supplementation ... Aims This study aimed to study the effect of magnesium sulfate (MgSO4) for reduction of postcardiac surgery arrhythmia. Setting and Design ...

5. amjmed.com amjmed.com/article/S0002-9343(04)00358-4/abstract

Magnesium prophylaxis for arrhythmias after cardiac surgery Administration of prophylactic magnesium reduced the risk of supraventricular arrhythmias after cardiac surgery by 23% (atrial fibrillation by 29%) and of ...

6. digitalcommons.fiu.edu digitalcommons.fiu.edu/cgi/viewcontent.cgi?article=1112&context=cnhs-studentprojects

Use of Magnesium to Decrease Postoperative Risk of ... 11 The implementation of magnesium sulfate to help reduce arrhythmias provides a cost-effective and safe adjunct to improve patient outcomes.

7. australiancriticalcare.com australiancriticalcare.com/article/S1036-7314(17)30377-6/abstract

Magnesium sulphate replacement therapy in cardiac ... The objective of this review was to identify evidence to inform clinical practice guidelines for magnesium sulphate (MgSO4) replacement ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11585403/

The Connection Between Magnesium and Heart Health Low levels of magnesium are associated with several cardiovascular issues, including arrhythmias, coronary artery disease, stroke, high blood pressure, and ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06564376/tailored-mgso4-supplementation-to-reduce-complications-in-pediatric-heart-surgery?activelyRecruiting=false&page=151&id=172&slug=circulation-disorders

Tailored MgSO4 Supplementation to Reduce ... This study tests two ways of measuring blood magnesium after heart surgery. Children who need heart surgery may have heart and kidney problems ...