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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,024
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.
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.
Alabama Resuscitation Center
Birmingham, Alabama, United States
UCSD-San Diego Resuscitation Center
San Diego, California, United States
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States
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.
Time frame: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
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
Time frame: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
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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.
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, United States
Seattle-King County Center for Resuscitation Research, University of Washington
Seattle, Washington, United States
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
Ottawa, Ontario, Canada
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
Toronto, Ontario, Canada