Amiodarone, Lidocaine or Placebo (ALPS) - Enrollment Complete

ENROLLMENT IS COMPLETE!  This study has completed enrollment and data analysis is beginning.  Thanks to all members of the community and to the paramedics who conducted this trial!  Results are expected to be known around April 2016.

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Pittsburgh is participating in the Amiodarone, Lidocaine, Placebo Study (ALPS).  You can comment on whether this trial should be conducted in this region in our survey.  ALPS is being conducted by the Resuscitation Outcomes Consortium (ROC) in multiple regions across the United States and Canada.  This trial plans to enroll up to 3,000 persons.

Cardiac arrest is the situation when the heart stops pumping blood and can happen as a complication of a heart attack, breathing problems or other medical conditions.  Cardiac arrest results in lack of oxygen and blood to vital organs, resulting in death within minutes if not treated.  Treatment of cardiac arrest is based on cardiopulmonary resuscitation (CPR) with chest compressions, artificial respirations, oxygen, and electrical shocks (defibrillation).  Drugs are often administered to augment CPR, but there are limited data about whether any drug actually improves patient outcomes.

ALPS will test whether more patients with cardiac arrest are discharged alive from the hospital when given the heart rhythm medication Amiodarone, or another heart rhythm medication Lidocaine, or neither medication (Placebo).   The placebo is a solution (made up of salt water) that looks like the other study drugs but has no medicine in it.

All patients who are treated for cardiac arrest will receive all of the standard treatments to save their lives, including chest compressions, oxygen, and electrical shocks (defibrillation) to restart the heart.   When the heart remains in disorganized electrical activity (fibrillation) after at least one electrical shock (defibrillation), paramedics and doctors are told to consider administering a heart rhythm medication.  Both amiodarone and lidocaine have been used for many years in this situation despite clear evidence of benefit.  The alternative to using these medicines is to continue using electrical shocks (defibrillation). 

Heart rhythm medications are used with the hope that they can help stabilize the heart after it has received an electrical shock. These medications do not prevent the need for an electrical shock.  In a prior study, amiodarone was better than lidocaine for improving survival to hospital admission, but did not clearly affect survival to hospital discharge.  If these medicines are not beneficial, then there is risk that the side effects of amiodarone or lidocaine might hurt some patients.   Potential side effects include increasing the rates of irregular heart rhythms (both drugs) and reducing blood pressure (amiodarone). 

In this trial, paramedics will carry “study drug” kits that contain either amiodarone, lidocaine or placebo in standard vials.  The paramedics and physicians will not be able to determine which drug is in the vial, but only one kit and drug will be used with each subject.  When a subject has had at least one rescue shock (defibrillation), but still remains in an irregular heart rhythm (fibrillation), the study kit drug will be administered.  Paramedics are trained in the use of all these drugs as well as in treatment of any complications for these drugs. 

Because subjects are unconscious during cardiac arrest, because cardiac arrest is unpredictable, and because treatments must be administered as soon as possible to be effective (within seconds), it is impossible to get informed consent prior to participation in this study.  Therefore, this trial is conducted using Exception from Informed Consent for Emergency Situations.  Subjects who are enrolled in this trial, or their Legally Authorized Representatives, will be informed about their participation as soon as feasible after the cardiac arrest.  

If you do not wish to participate in this trial, you should contact us.