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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Cardiac Arrest
Title   Amiodarone, Lidocaine or Neither for Out-of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
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 secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of: a) Lidocaine compared to placebo, b) PM101 compared to lidocaine.
IRB Number   Pro3084
Inclusion/Notes   INCLUSION:
  • Age at least 18 years or local age of consent.

  • Non-traumatic out-of-hospital cardiac arrest treated by a ROC EMS agency 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 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.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Contact Name   Dixie Carter - dixie.climer@utsouthwestern.edu

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