Inhaled Nitric Oxide after Out of Hospital Cardiac Arrest (PROPOSED STUDY)

Cardiac arrest is a condition where the heart stops beating, and which leads to death unless treated immediately. Up to 90% of the people with cardiac arrest die. We are studying the best way to treat patients with cardiac arrest. 

 

Specifically, we are conducting a research study, sponsored by Mallinckrodt Pharmaceuticals, in which we compare the use of nitric oxide, a colorless gas to standard of care procedures after people are resuscitated from cardiac arrest. Previous studies have shown that inhaled nitric oxide may reduce heart and brain injury when administered shortly after cardiac arrest. The University of Pittsburgh plans to enroll 130 subjects aged 18 years or older in this study through December 2017.  Inhaled nitric oxide (iNO) is FDA approved as a treatment for respiratory failure in newborn babies, but is not FDA approved in the patient population that we wish to study.

 

In this study, patients will be assigned by chance (randomly) into one of two study treatment plans. In both plans, paramedics and medical professionals in the hospital will perform CPR and emergency interventions (for example, electrical shocks to the heart and medications) as indicated to restore a heartbeat.  The only difference between the two plans will be the choice of using iNO or not. All other interventions will be usual standard care.  The purpose of the research study is to decide if the use of iNO is better than standard of care.  We will also collect some blood and urine samples to look at how the body reacts to iNO versus standard procedures.

 

There are risks associated with all cardiac arrests including unstable blood pressure, bruising or breaking of ribs, pneumonia, injury to liver or other internal organs, collapse of the lungs, injury from the tube placed in the throat, and pain in the chest.  All patients who receive CPR have a risk of death, brain injury, stroke and bleeding in the brain. We will minimize these risks by having only trained emergency rescuers experienced in CPR and resuscitation perform and direct these plans.  These providers will be able to perform all interventions they believe are best able to restore a heartbeat.  These risks are not known to be increased by the use of iNO. 

 

The dosage and length of administration planned for this study has been well tolerated in critically ill patients, and adverse events resulting from this treatment are not expected.

 

Normally, researchers get permission (consent) before a person can be included in a study.  A person having a cardiac arrest will not be able to give consent at the time they could be enrolled.  Since a cardiac arrest must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study, so the person will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC).  Once the representative is located or the patient wakes up, they will be asked to give their permission to continue in the study.

 

We would like to hear your opinion of this study.  Please click here to complete our survey.