Phase 3
Completed N=3,024
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Source: ClinicalTrials.gov NCT01401647 ↗Enrolled (actual)
3,024
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge — 237; 233; 222 participants
◆ Published Evidence
Highly cited
460citations · ~46 / year
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
Summary
The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.
Linked Publications (2)
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Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest.
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Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge |
237; 233; 222 | — |
| SECONDARY Number of Participants Scoring at or Below a 3 on the MRS Scale |
182; 172; 175 | — |
Eligibility Criteria
Inclusion Criteria
- Age at least 18 years or local age of consent
- Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability
- 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)
- Incessant or recurrent VF/VT after receipt of ≥ 1 shocks
- Established vascular access
Exclusion Criteria
- Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT
- Written advance directive to not attempt resuscitation (DNAR)
- Blunt, penetrating, or burn-related injury
- Exsanguination
- Protected populations (prisoners, pregnancy, children under local age of consent)
- Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers
- Prior receipt of open label lidocaine or amiodarone during resuscitation
Data sourced from ClinicalTrials.gov (NCT01401647) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.