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

Completed · Phase 3

Conditions studied: Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT01401647

Run by

University of Washington

People needed

3024

Starts

2012-05-01

Expected to finish

2016-01-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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