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

March 18, 2017 updated by: Susanne May, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) 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.

Study Type

Interventional

Enrollment (Actual)

3024

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
      • Toronto, Ontario, Canada
        • Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Resuscitation Center
    • California
      • San Diego, California, United States, 92103
        • UCSD-San Diego Resuscitation Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • The Pittsburgh Resuscitation Network, University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390
        • Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Seattle-King County Center for Resuscitation Research, University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee Resuscitation Network, Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amiodarone
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
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.
Other Names:
  • PM 101, Nexterone
Active Comparator: Lidocaine
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Drug: 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 Names:
  • lidocaine hydrochloride
Placebo Comparator: Normal saline
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Time Frame: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
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.
Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Scoring at or Below a 3 on the MRS Scale
Time Frame: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead
Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Investigators

  • Study Chair: Myron Weisfeldt, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 18, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40605-D
  • 5U01HL077863-07 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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