Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS)

University of Washington

Status and phase: Completed; Phase 3

Conditions: Cardiac Arrest

Treatments: Drug: amiodarone; Other: Normal saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry; NIH

Identifiers

NCT01401647

5U01HL077863-07 (U.S. NIH Grant/Contract)

40605-D

Details and patient eligibility

About

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.

Full description

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 (PM101) compared to placebo.

The corresponding null hypothesis is that survival to hospital discharge is identically distributed when out-of-hospital VF/VT arrest is treated with PM101 or placebo.

The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of:

1. Lidocaine compared to placebo
2. PM101 compared to lidocaine The corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital VF/VT arrest is treated with lidocaine as compared with placebo, and with PM101 as compared with lidocaine.

Enrollment: 3,024 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

3,024 participants in 3 patient groups, including a placebo group

Amiodarone

Active Comparator group

Description:

Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.

Treatment:

Drug: amiodarone

Lidocaine

Active Comparator group

Description:

IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.

Treatment:

Drug: Lidocaine

Normal saline

Placebo Comparator group

Description:

IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.

Treatment:

Other: Normal saline