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

Trial Summary

What is the purpose of this trial?

The purpose of this pilot interventional study is to collect preliminary data on administering magnesium sulfate as a neuroprotective medication in patients who achieved Return of Spontaneous Circulation (ROSC) following Cardiac Arrest (CA). The primary aims are to assess the feasibility and safety of administering magnesium and measure serum markers of neuronal injury at prespecified time points in the post-cardiac arrest period. Because this is a pilot study with a limited sample size, the primary objective is to evaluate the precision and stability of the collected measures to inform the design and formal analysis in a larger trial.

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.

What evidence supports the effectiveness of the drug magnesium sulfate for cardiac arrest?

Research shows that magnesium sulfate can help reduce mortality in heart attack patients and improve heart function after injury. It has also been used successfully in a case of prolonged cardiac arrest, helping to restore a stable heart rhythm when other treatments failed. ^{1 2 3 4 5}

Is magnesium sulfate generally safe for use in humans?

Magnesium sulfate is generally safe when used correctly, but overdoses can cause serious side effects like heart problems and breathing difficulties. It's important for medical staff to be careful with dosing to avoid these risks. ^{6 7 8 9 10}

How does the drug magnesium sulfate differ from other treatments for cardiac arrest?

Magnesium sulfate is unique in cardiac arrest treatment because it can help restore a stable heart rhythm when other standard therapies fail, as seen in a case where it successfully converted a life-threatening heart rhythm to a normal one after prolonged cardiac arrest. It works by reducing the incidence of dangerous heart rhythms and may also help relax the heart muscle during and after low oxygen conditions. ^{1 4 7 11 12}

Research Team

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Resuscitation from prolonged cardiac arrest with high-dose intravenous magnesium sulfate. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Long-term outcome after intravenous magnesium sulphate in suspected acute myocardial infarction: the second Leicester Intravenous Magnesium Intervention Trial (LIMIT-2) [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Magnesium sulfate in the treatment of refractory ventricular fibrillation in the prehospital setting. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

[Magnesium sulfate in acute myocardial infarction]. [2013]

5. Israel pubmed.ncbi.nlm.nih.gov

[Body magnesium--the spark of life]. [2017]

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

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

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

Deliberate overdose with Epsom salts. [2021]

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

Iatrogenic magnesium overdose: two case reports. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Use of magnesium sulfate as an anticonvulsant in severe pregnancy toxemia and eclampsia]. [2006]

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

Management of persistent wide QRS in flecainide overdose with magnesium sulphate. [2013]

11. Germany pubmed.ncbi.nlm.nih.gov

The role of magnesium sulfate in the intensive care unit. [2023]

12. Ireland pubmed.ncbi.nlm.nih.gov

Magnesium sulfate solution dramatically improves immediate recovery of rats from hypoxia. [2019]