Status:
COMPLETED
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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) co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
3024 Patients enrolled
Trial Details
Trial ID
NCT01401647
Start Date
May 1 2012
End Date
January 1 2016
Last Update
April 17 2017
Active Locations (9)
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1
Alabama Resuscitation Center
Birmingham, Alabama, United States, 35294
2
UCSD-San Diego Resuscitation Center
San Diego, California, United States, 92103
3
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 97239
4
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261