Magnesium for Cardiac Arrest

Overseen By Natalia Leontovich

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: Age, Traumatic cardiac arrests, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 90

Duration: 3 weeks

178 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium sulfate can protect the brain after cardiac arrest, when the heart stops suddenly and then resumes beating. The goal is to determine the treatment's safety and practicality while monitoring for any signs of brain injury post-event. Participants will receive either magnesium sulfate or a placebo, a harmless saline solution resembling the treatment. Ideal candidates are those who have experienced a cardiac arrest and whose heart restarted within the last two hours. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that magnesium sulfate is likely to be safe for humans?

Research has shown that magnesium sulfate is generally safe when used properly. However, excessive intake can lead to serious side effects. Studies have found that high blood magnesium levels can cause issues like breathing difficulties and heart problems. These risks usually occur at doses much higher than those typically used in medical treatments.

This trial is in its early stages, focusing primarily on safety for participants. Since magnesium sulfate is already used in medicine for other conditions, this provides some confidence about its safety. However, as with any new study, close monitoring is important. Researchers will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cardiac arrest?

Most treatments for cardiac arrest focus on restoring blood flow through CPR and defibrillation, sometimes using drugs like epinephrine and amiodarone. But Magnesium Sulfate offers a unique approach by potentially stabilizing heart rhythms through its role as a natural calcium antagonist. This means it can help calm over-excited heart cells and reduce abnormal rhythms during cardiac arrest. Researchers are particularly excited about its dual action—providing an initial magnesium boost followed by a continuous dosage, which could offer a more sustained benefit during the critical moments of resuscitation.

What evidence suggests that magnesium sulfate might be an effective treatment for cardiac arrest?

Research suggests that magnesium sulfate, which participants in this trial may receive, might help protect the brain after a heart attack. In animal studies, magnesium reduced brain damage and improved nerve function when administered before stopping blood flow to the brain. Another study showed that magnesium improved survival after oxygen deprivation. However, a review of different studies found that administering magnesium during resuscitation did not significantly improve outcomes compared to a placebo. Despite these mixed results, the potential of magnesium to aid in heart-related issues remains of interest. ^{4 6 7 8 9}

Who Is on the Research Team?

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients who have had a cardiac arrest and were successfully resuscitated (ROSC). It's a preliminary study, so the main goal is to see if it's feasible and safe to give magnesium sulfate as brain protection after the event. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Documented post-cardiac arrest patient with Return of Spontaneous Circulation (ROSC) achieved <2 hours prior to recruitment

Exclusion Criteria

Traumatic cardiac arrests

Plan for withdrawal of life support within 72 hours of ROSC

Known prisoners at the time of the cardiac arrest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive magnesium sulfate or saline solution following cardiac arrest

3 weeks

In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Regular assessments until day 90

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

Trial Overview The study tests whether giving magnesium sulfate can protect the brain after someone has been brought back from cardiac arrest. Patients will be compared with those receiving saline, which is a standard treatment without active medication.

How Is the Trial Designed?

Group I: Magnesium Sulfate Experimental Treatment 1 Intervention

Treatment of initial magnesium sulfate bolus followed by a continuous drip.

Group II: Saline solution Placebo Group 1 Intervention

Treatment of equivalent volume of normal saline.

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A 73-year-old man experienced an iatrogenic overdose of magnesium sulfate during treatment for suspected acute myocardial infarction, leading to serious side effects like bradycardia, hypotension, and apnea.

This case highlights the need for better education among emergency department staff regarding proper dosing and potential adverse effects of magnesium sulfate, especially since such overdoses in cardiac patients have not been previously reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic magnesium overdose in a patient with suspected acute myocardial infarction. Frohna, WJ.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11133868/

The role of magnesium in cardiac arrest - PMC In rats, MgSO4 reduced cerebral injury and preserved neurologic function when administered 2 days before transient global ischemia (21).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/002822439290217M

cardiopulmonary arrest resulting from magnesium sulfate ... ... magnesium sulfate overdosage can result in cardiac arrest and thus have fatal consequences. Therefore, it appears reasonable that nature placed TAS2R7 as ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9259061/

Magnesium sulfate solution dramatically improves ... Magnesium sulfate fully reversed the hypoxic increase of LVP and improved survival after 12 min of hypoxia from approximately 15 (control) to 100%.

4. journals.viamedica.pl journals.viamedica.pl/disaster_and_emergency_medicine/article/view/70952

Place of magnesium sulfate in cardiopulmonary ... This meta-analysis indicates no statistically significant benefit of resuscitation with magnesium sulfate compared to the placebo.

5. ahajournals.org ahajournals.org/doi/10.1161/01.cir.92.9.2617

Magnesium Sulfate Reduces Myocardial Infarct Size When ... The data suggest that magnesium infusion during a coronary occlusion has a significant benefit in reducing the IS in this model.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK554553/

Magnesium Sulfate - StatPearls - NCBI Bookshelf Respiratory paralysis: 6.0 to 7.5 mmol/L (12 to 15 meq/L). Cardiac arrest: 12.5 to 15.0 mmol/L (25 to 30 meq/L). Go to: Toxicity. If patients ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3030276/

Deliberate overdose with Epsom salts - PMC Although clinical severity does not always correlate with serum magnesium values, risk of cardiac arrest occurs with concentrations >6 mmol/l.

8. link.springer.com link.springer.com/article/10.1007/s40278-020-73972-4

Magnesium sulfate overdose and misuse | Reactions Weekly A 40-year-old woman developed cardiac arrest, seizure and diffuse anoxic injury secondary to magnesium sulfate toxicity following its overdose ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0736467901004620

Hypermagnesemia-induced fatality following epsom salt ... We report a case of severe hypermagnesemia and normal renal function following chronic gargling with Epsom Salt that resulted in coma and cardiopulmonary arrest ...