Amiodarone (PM101), Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
The goal of Amiodarone, Lidocaine or Placebo Study (ALPS) is to determine if survival to hospital discharge is improved with early (and if necessary) repeated therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (PM101) compared to no antiarrhythmic drug (placebo) or lidocaine. It will compare the benefit of what is believed (but as yet unproven) to be the most effective antiarrhythmic drug (amiodarone) against the traditional standard drug (lidocaine) and against neither (placebo) in shock-resistant cardiac arrest. As such, it will potentially answer 2 critical questions: (1) are antiarrhythmic drugs effective for the treatment of VF cardiac arrest[DELTA] (2) is amiodarone preferable to lidocaine for such treatment[DELTA] Answering these questions will determine the proven role (if any) of antiarrhythmic drugs for future generations of patients with out-of-hospital cardiac arrest.
Patients who meet the study inclusion criteria are randomized (1:1:1) to receive amiodarone, lidocaine or neither medication (a placebo made up of salt water), in addition to all other standard treatment measures for cardiac arrest given by the EMS. Patients receive standard medical care when admitted to the hospital.
The relevant questions regarding antiarrhythmic drug treatment are not just which therapy is best but also whether drug treatment itself is beneficial. To adequately address these questions requires not only a comparison of the most promising available drug therapies, but the inclusion of a placebo control. Inclusion of placebo is both scientifically necessary and ethically justifiable. In its absence, proof of one agent[Right Quote]s apparent superiority over another might
only mean that one drug is less harmful than the other, not necessarily that either is truly beneficial. Antiarrhythmic medications (amiodarone, lidocaine) are frequently used as part of advanced care to treat ventricular arrhythmias that persist or recur during a cardiac arrest. Although much is known about the pharmacological effects of these drugs, there is a considerable gap in knowledge between our understanding of their mechanisms of action and whether their use actually improves survival after cardiac arrest. No pharmacologic agent has ever been demonstrated to improve survival to hospital discharge after cardiac arrest. It is not known whether these drugs may cause more harm than good.
Eligible patients will be randomly allocated to lidocaine:placebo:PM101 in a proportion of 1:1:1,
respectively, with distribution determined by the Data Coordinating Center. The contents of the study drug kit for a given case will reflect the subject[Right Quote]s randomization assignment and not require any randomization efforts in the field by EMS personnel.
a) Age at least 18 years or local age of consent
b) Non-traumatic out-of-hospital cardiac arrest treated by a ROC EMS agency with advanced life
c) VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion
of another arrhythmia (such as transient asystole or pulseless electrical activity)
d) Incessant or recurrent VF/VT after receipt of >= 1 shocks
e) Established vascular access
f) "Other" has been selectd to designate all other subjects greater than or equal to 18 years of age (except prisoners, pregnant women, children under local age of consent) who could be employees, Faculty, trainees, Residents, etc. of the site.