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

Phase 3

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Amiodarone	amiodarone	Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
Lidocaine	Lidocaine	IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Scoring at or Below a 3 on the MRS Scale	Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.	Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead

Locations (9): Alabama Resuscitation Center
🇺🇸
Birmingham, Alabama, United States
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
🇺🇸
Portland, Oregon, United States
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
🇨🇦
Ottawa, Ontario, Canada
Seattle-King County Center for Resuscitation Research, University of Washington
🇺🇸
Seattle, Washington, United States
The Pittsburgh Resuscitation Network, University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
🇨🇦
Toronto, Ontario, Canada
UCSD-San Diego Resuscitation Center
🇺🇸
San Diego, California, United States
Milwaukee Resuscitation Network, Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States