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Tomlinson
ALPS study
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to
Ventricular Fibrillation orTachycardia (ALPS)
The goal of ALPS is to determine if survival to hospital discharge is improved
with early (and if necessary) repeated therapeutic administration of a new CaptisolEnabled 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? (2) is amiodarone
preferable to lidocaine for such treatment?
Answering these questions will determine the proven role (if any) of
antiarrhythmic drugs for future generations of patients with out-of-hospital cardiac arrest.
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.
The ROC study is powered to answer those questions by recruiting 3,000 plus VF VT
patients over the next 3 years.
Primary Outcome Measure:
Survival to hospital discharge. Patients will be followed from the time of the CA
until death in the field, ED or hospital, or hospital discharge, whichever occurs first. The
longest estimated period for the outcome measure assessment is 6 months from the
date of the event. Patients may die in the field (outside of the hospital at the time of the
cardiac arrest), at the emergency room, in the hospital, or they are discharged alive
from the hospital. There is no average time frame for the hospitalization period as it may
be less than one day or it can last 3-6 months or more.
The study will be done at 10 locations across the U.S. and Canada. Almost 70
EMS organizations, involving more than 10,000 EMS providers who serve a combined
population of nearly 15 million people from diverse urban, suburban and rural regions
will participate in the study. Approximately 3,000 patients will be enrolled at all of the
ROC (Research Outcomes Consortium) regions in the United States and Canada.