PROTECT Research Study

The PROTECT Study is for people brought to the MaineHealth Maine Medical Center Portland (MHMMCP) emergency department after receiving cardiopulmonary resuscitation (CPR) for cardiac arrest. The study will tell us if giving antibiotics early after cardiac arrest stops pneumonia, a lung infection, and helps people survive and recover.

It will also tell us if early antibiotics decrease injury in the body, and how they affect normal bacteria. We do not know the best way to stop pneumonia after cardiac arrest. There are risks and benefits to each approach. This study will answer the question: Do early antibiotics after cardiac arrest stop pneumonia and help people recover?

What is cardiac arrest and why is pneumonia important?
 

Cardiac arrest is when the heart suddenly stops pumping blood. In adults, this may be the result of a heart attack or other stress on the body. Pneumonia, a lung infection, may make it harder to survive cardiac arrest.

• Only 4 out of 10 people who have an out-of-hospital arrest make it to the hospital alive
• Of the 4 people who make it to the hospital alive, only 1 or 2 will leave the hospital alive
• Lung infection may happen to 6 out of 10 patients and may lower their ability survive and live normally

Who can participate in the study?
This study is for patients experiencing cardiac arrest, who are not awake, and are treated in the hospital by lowering their body temperature. Pneumonia, a lung infection, is common in these situations, but we do not know if giving antibiotics can stop it. All patients and families who choose to be in the study will be randomly placed in 1 of 2 groups:

• Group #1: ceftriaxone (antibiotic) two times a day for three days total
• Group #2: placebo (salt water) two times a day for three days total

How will you get informed consent?
 

Federal regulations require patients give informed consent before a research study. This means that they understand the risks and benefits of the study and choose to be part of it. Most patients are not able to give informed consent because they are unconscious. A family member or legally authorized representative may give informed consent if the patient us unable. If family or authorized representatives are not available, patients can be enrolled in the study under an Exception from Informed Consent for Emergency Research. In this case, the patient’s medical team decides if the patient should be in the research study. The patient or family can later decide to stop having their information collected.

What are the potential benefits of the study? 
 

It is not possible to know whether you will benefit from participation in this study. However, your participation may help others in the future as a result of knowledge gained from this research. The risks and benefits for the two study groups are equal. We do not yet know which treatment is best.

What are the potential risks?
 

Antibiotic prophylaxis is sometimes given after cardiac arrest to prevent pneumonia, but it can also cause serious side effects including allergic reactions, gallbladder injury and clostridium difficile-associated diarrhea. All patients will be monitored for side effects and removed from the study if there is potential or actual harm.