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

Study Overview
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Brief Summary
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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
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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: Lidocaine compared to placebo 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.

Official Title
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Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: amiodarone
* Drug: Lidocaine
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amiodarone<br>Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation. | Drug: amiodarone<br>* 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists.<br>* Other names: PM 101, Nexterone;|
| Active Comparator: Lidocaine<br>IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation. | Drug: Lidocaine<br>* 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists.<br>* Other names: lidocaine hydrochloride;|
| Placebo Comparator: Normal saline<br>IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation. | Other: Normal saline<br>* 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Scoring at or Below a 3 on the MRS Scale | 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 | Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, cardiopulmonary resuscitation, ventricular fibrillation, pulseless ventricular tachycardia, Non-traumatic Out of Hospital Cardiac Arrest (OOHCA)