Resuscitation Outcomes Consortium (ROC) - ALPS

Amiodarone, Lidocaine, Placebo Study

Enrollment Closed on October 24th, 2015

Overview

There are approximately half a million cardiac arrests which occur in the United States each year. Nearly two thirds or about 350,000 cardiac arrests occur outside the hospital. Nationally, only about 5% of cardiac arrest victims survive. Cardiac arrest occurs when the heart stops beating. When the heart stops beating, blood-containing oxygen does not get to vital organs, such as the brain, lungs, kidneys, and the heart itself. When oxygen is not available, organs may be permanently damaged or the patient may die. Life-supporting interventions must be given immediately in the field to save their life. Standard care for cardiac arrest includes providing chest compressions, breathing assistance and the use of heart rhythm medications (Amiodarone and/or Lidocaine) in some instances. Even with these treatments, only 10-15% of patients survive cardiac arrest with good brain function in our local community. This study is being done to figure out the best method of treating those who suffer from cardiac arrest outside of the hospital, in order to ensure the highest rate of survival.

Purpose

The purpose of this study is to determine whether the use of certain heart rhythm medications will improve the chances of patients surviving to hospital discharge following a cardiac arrest outside of the hospital. This study will test whether more patients are discharged alive from the hospital when given the heart rhythm medication Amiodarone compared to Lidocaine (another heart rhythm medication) or neither medication, that is, something called a placebo. The placebo is a solution (made up of salt water) that looks like the study drug but has no medicine in it. Before this study begins, participating agencies who respond to emergency calls will be instructed on how the study is done, and treat the patient according to the study plan that is described below. Amiodarone and Lidocaine are frequently used as part of advanced care to treat heart arrhythmias that persist or recur during a cardiac arrest. Heart rhythm medications are used with the hope that they can help stabilize the heart after it has been successfully restarted following an electrical shock. In a prior study, Amiodarone was better than Lidocaine in improving short term outcomes (survival to hospital admission), but not long term outcomes (survival to hospital discharge). This study will give insight into which of these medications are most effective, or if they, in fact, do more harm than good.

Consent Information

Normally, before someone joins a research study, it is discussed with him or her in detail. Also, a consent form that lists the purposes of the study, the possible benefits, and the risks from being in the study is reviewed with the person. If the person agrees to join the study, the consent form is signed. In most cases, this takes place before any study procedures are done or treatment is given. This process is called "informed consent" and ensures that the person volunteered for the research study only after being given the information necessary to make an informed decision.

For this study, investigators will not be able to get written informed consent from each study participant, due to them being unconscious while in cardiac arrest. Instead, the investigators will try to inform the community about the study and address any concerns or questions before the study is approved to begin. We will do this by:

  • This website
  • Community meetings
  • Online and mailed surveys
  • Newspapers and Newsletters

People will be given the choice to refuse being in the study by contacting the investigators at OHSU and asking to opt-out.

For more information about the study, read the official ALPS NIH Press release   or the ALPS OHSU Press release.

Contact Us

If you still have questions after reviewing the website, please contact us via e-mail at roc@ohsu.edu. (Note that the confidentiality of e-mail communications cannot be guaranteed) or at (503) 494-8083 where you will be able to leave a voice message. The e-mail and voice mails are checked regularly and you can expect to receive a reply within 3 days.