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

Cardiac Arrest Clinical Trial

— ALPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01401647
• Other study ID #: 40605-B
• Secondary ID: 5U01HL077863-07
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 8, 2011
• Last updated: February 25, 2016
• Start date: May 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Intervention

Drug:
• amiodarone
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.
• Lidocaine
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.

Other:
• 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.

Locations

Country	Name	City	State
Canada	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
United States	Alabama Resuscitation Center	Birmingham	Alabama
United States	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Dallas	Texas
United States	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The Pittsburgh Resuscitation Network, University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University	Portland	Oregon
United States	UCSD-San Diego Resuscitation Center	San Diego	California
United States	Seattle-King County Center for Resuscitation Research, University of Washington	Seattle	Washington

Sponsors (7)

Lead Sponsor	Collaborator
University of Washington	American Heart Association, Canadian Institutes of Health Research (CIHR), Defence Research and Development Canada, Heart and Stroke Foundation of Canada, National Heart, Lung, and Blood Institute (NHLBI), U.S. Army Medical Research and Materiel Command

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to hospital discharge	Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months or more.	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.	No
Secondary	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.	Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.	Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.	Yes

External Links

•   ROC Public Homepage