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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Susanne May, University of Washington
ClinicalTrials.gov Identifier:
NCT01401647
First received: July 8, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Drug: amiodarone
Drug: Lidocaine
Other: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 3000
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years or local age of consent
  • Non-traumatic out-of-hospital cardiac arrest treated by 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401647

Locations
United States, Alabama
Alabama Resuscitation Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jeffrey Kerby, MD       jeffrey.kerby@ccc.uab.edu   
United States, California
UCSD-San Diego Resuscitation Center Recruiting
San Diego, California, United States, 92103
Contact: Gary Vilke, MD       gmvilke@ucsd.edu   
United States, Oregon
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Mohamud Daya, MD       dayam@ohsu.edu   
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Clif Callaway, MD    412-647-9047    callawaycw@upmc.edu   
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ahamed Idris, MD       aidris@sbcglobal.net   
United States, Washington
Seattle-King County Center for Resuscitation Research, University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Peter Kudenchuk, MD       kudenchu@u.washington.edu   
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tom Aufderheide, MD    414-805-6452    taufderh@mcw.edu   
Canada, Ontario
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Recruiting
Ottawa, Ontario, Canada
Contact: Ian Stiell, MD       istiell@ohri.ca   
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto Recruiting
Toronto, Ontario, Canada
Contact: Laurie Morrison, MD       morrisonl@smh.ca   
Sponsors and Collaborators
University of Washington
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
American Heart Association
Defence Research and Development Canada
U.S. Army Medical Research and Materiel Command
Investigators
Study Chair: Myron Weisfeldt, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Susanne May, ROC Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01401647     History of Changes
Other Study ID Numbers: 40605-B, 5U01HL077863-07
Study First Received: July 8, 2011
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by University of Washington:
cardiac arrest
cardiopulmonary resuscitation
ventricular fibrillation
pulseless ventricular tachycardia
Non-traumatic OOH-CA with VF or pulseless VT

Additional relevant MeSH terms:
Heart Arrest
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Lidocaine
Amiodarone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on October 16, 2014