Overview

This trial is active, not recruiting.

Condition cardiac arrest
Treatments amiodarone, lidocaine, normal saline
Phase phase 3
Sponsor University of Washington
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date May 2012
End date October 2015
Trial size 3000 participants
Trial identifier NCT01401647, 40605-B, 5U01HL077863-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
amiodarone PM 101, Nexterone
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.
(Active Comparator)
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
lidocaine lidocaine hydrochloride
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.
(Placebo Comparator)
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
normal saline
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.

Primary Outcomes

Measure
Survival to hospital discharge
time frame: Patients will be followed from the time of the CA until death in the field, ED or hospital, or hospital discharge, whichever occurs first. The longest estimated period for the outcome measure assessment is 6 months from the date of the event CA.

Secondary Outcomes

Measure
The secondary endpoint of the trial is survival to discharge with a Modified Rankin Score (MRS) ≤ 3 and will be compared in patients randomized to PM101 versus placebo, lidocaine versus placebo, and PM101 versus lidocaine in the efficacy population.
time frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Washington.