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Any adult patient who experiences a cardiac arrest in one of the participating hospitals might be included in a new research study that aims to improve survival and reduce brain injury.

This means that, in the extremely unlikely event that you suffer a cardiac arrest, you might be included in this study unless you explicitly choose to opt-out.

The purpose of this study is to assess the how a medication called magnesium may reduce brain damage and affect survival in patients who experience a cardiac arrest. Magnesium will be administered in addition to all standard cardiac arrest treatments, including cardiopulmonary resuscitation, or CPR. These standard treatments have not changed significantly in the last 60 years. In fact, CPR is only able to restore life in about 2 out of 10 people whose hearts stops beating. There is a need to develop new treatments to improve the likelihood of bringing back life and preventing brain injury in cardiac arrest patients.

Although magnesium is an FDA (Food and Drug Administration) approved medication routinely used for other medical emergencies, such as to prevent seizures in pregnant women with dangerously high blood pressures, the FDA has not approved the use of Magnesium specifically for cardiac arrest. Previous research studies have shown potential benefits for cardiac arrest patients. For this reason, Magnesium is considered an experimental drug for the purpose of this study and has been approved by the FDA for use in this research study under an Investigational New Drug (IND) application.

Why This Study May Be of Interest to You

Although you are unlikely to experience an unexpected cardiac arrest, it can happen to anyone, at home or in the hospital. Cardiac arrest is a major medical emergency where the heart stops beating, inevitably leading to death in everyone unless they receive resuscitation. Even with treatment, there is still a very high rate of death in individuals who experience a cardiac arrest, and many cardiac arrest patients suffer some level of brain injury due to the effects of lack of oxygen. New treatments for cardiac arrest, such as magnesium, are urgently needed to affect survival and reduce brain damage.

Who May Participate in This Study

Adult patients aged 18 years or older who experience a cardiac arrest in one the following participating hospital centers, or who are brought to a participating hospital while experiencing an out-of-hospital cardiac arrest, are eligible for the study.

Hospital centers that are participating in this study include, Tisch Hospital, NYU Langone Hospital—Brooklyn, NYU Langone Hospital—Long Island, and NYC Health + Hospitals/Bellevue.

How Will This Study Take Place?

If you are eligible for the study, you will be randomized (randomly assigned, by chance, like flipping a coin) to one of two arms. The two arms are the control group and the intervention group. The intervention group will receive normal CPR with the addition of magnesium. The control group will receive normal CPR with an equivalent amount of saline solution.

In order to receive the greatest benefit, you will be given magnesium within 2 hours after your heart has restarted. The full course will be given over 24 hours. Throughout this period, you will be receiving all standard cardiac arrest management in addition to magnesium, which may include targeted temperature management (treatment to achieve and maintain a specific body temperature), ventilator management, and routine blood monitoring.

Due to the unexpected and urgent nature of cardiac arrest, and the fact that cardiac arrest patients will be unresponsive, this study requires that magnesium be given without first obtaining your consent.

We will ask the patient’s authorized representative, called their Legal Authorized Representative (LAR), to give consent for them as soon as we can. If the LAR is unable to be reached, and the patient cannot give consent themselves, a family member may provide an opportunity to object to the subject’s enrollment in the study. If no one is able to provide consent and there is no objection to participation, a waiver of consent has been granted by the FDA and NYU’s Institutional Review Board (IRB).

The study will require an interview 30 days post-cardiac arrest. If you agree to participate in the interview, you will be able to complete the interview with the research team via telephone, videoconferencing software, or during an in-person visit.

We expect to enroll approximately 178 patients at approximately 20 sites nationally and internationally.

What Are the Risks of Participating In This Study?

There is very little risk associated with administering magnesium. Magnesium is available over the counter and routinely taken as a supplement. As with any medication, there may be side effects if too high of a dose is consumed. Rare adverse effects associated with very high magnesium levels may include:

• Nausea
• Flushing
• Headaches, drowsiness
• Hypotension (low blood pressure)
• Loss of muscle function
• Respiratory failure

These side effects are not relevant to cardiac arrest patients due to the fact that patients are unconscious and receiving maximum life support measures, including blood pressure medication and mechanical ventilation, and are closely monitored in the Intensive Care Unit (ICU).

Magnesium levels will be measured routinely every 6 hours as determined in cardiac arrest standard of care and more frequently if needed. If any adverse effects as listed above are identified, the clinical team will discontinue the medication and symptoms will be treated in accordance with the local hospital standard treatment protocols.

What Are the Benefits of Participating In This Study?

There may or may not be direct benefit to participants. However, previous studies have shown possible benefits for patients who received magnesium following cardiac arrest. Receiving magnesium may reduce brain injury, affect survival rates, and affect quality of life in patients who suffer from a cardiac arrest. The information that is gained from this study may also lead to improvements in medical practices, which may help future patients who experience cardiac arrests.

How Can I Participate In This Study?

Anyone who experiences a cardiac arrest while admitted to a participating hospital center and meets eligibility criteria might be included in this study.

If you would like to learn more about this study, or opt-out of the study, please contact the study team:

Participating Site	Email	Phone
[INSERT HOSPITAL]	[INSERT EMAIL]	[INSERT PHONE]
[INSERT HOSPITAL]	[INSERT EMAIL]	[INSERT PHONE]
[INSERT HOSPITAL]	[INSERT EMAIL]	[INSERT PHONE]
[INSERT HOSPITAL]	[INSERT EMAIL]	[INSERT PHONE]
[INSERT HOSPITAL]	[INSERT EMAIL]	[INSERT PHONE]

Anyone may decline to participate in this study at any time, without consequences. Standard post-cardiac arrest medical care will not be impacted if someone decides not to participate in this study. Please follow the "Opt-Out" link on this website if you would like to opt out of participating in this study.