Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
This trial is active, not recruiting.
|Treatments||amiodarone, lidocaine, normal saline|
|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|
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|
|Birmingham, AL||Alabama Resuscitation Center||no longer recruiting|
|San Diego, CA||UCSD-San Diego Resuscitation Center||no longer recruiting|
|Portland, OR||Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University||no longer recruiting|
|Pittsburgh, PA||The Pittsburgh Resuscitation Network, University of Pittsburgh||no longer recruiting|
|Dallas, TX||Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center||no longer recruiting|
|Seattle, WA||Seattle-King County Center for Resuscitation Research, University of Washington||no longer recruiting|
|Milwaukee, WI||Milwaukee Resuscitation Network, Medical College of Wisconsin||no longer recruiting|
|Ottawa, Canada||University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research||no longer recruiting|
|Toronto, Canada||Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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.
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.
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
|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.|
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