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

Sponsor:	University of Washington
Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) 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

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 III

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:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

MedlinePlus related topics: Cardiac Arrest

Drug Information available for: Amiodarone hydrochloride Amidox Lidocaine Amiodarone

U.S. FDA Resources

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:	September 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	September 2014 (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.
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:

Lidocaine compared to placebo
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

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

Locations

United States, Alabama
Alabama Resuscitation Center	Not yet recruiting
Birmingham, Alabama, United States
Contact: Jeffrey Kerby, MD jeffrey.kerby@ccc.uab.edu
United States, California
UCSD-San Diego Resuscitation Center	Not yet recruiting
San Diego, California, United States
Contact: Dan Davis, MD davismd@cox.net
United States, Oregon
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University	Not yet recruiting
Portland, Oregon, United States
Contact: Mohamud Daya, MD
United States, Pennsylvania
The Pittsburgh Resuscitation Network, University of Pittsburgh	Not yet recruiting
Pittsburgh, Pennsylvania, United States
Contact: Clif Callaway, MD callawaycw@upmc.edu
United States, Texas
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Not yet recruiting
Dallas, Texas, United States
Contact: Ahamed Idris, MD aidris@sbcglobal.net
United States, Washington
Seattle-King County Center for Resuscitation Research, University of Washington	Not yet recruiting
Seattle, Washington, United States
Contact: Peter Kudenchuk, MD kudenchu@u.washington.edu
United States, Wisconsin
Milwaukee Resuscitation Network, Medical College of Wisconsin	Not yet recruiting
Milwaukee, Wisconsin, United States
Contact: Tom Aufderheide, MD taufderh@mcw.edu
Canada, Ontario
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research	Not yet recruiting
Ottawa, Ontario, Canada
Contact: Ian Stiell, MD istiell@ohri.ca
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto	Not yet recruiting
Toronto, Ontario, Canada
Contact: Laurie Morrison, MD morrisonl@smh.ca

Sponsors and Collaborators

University of Washington

National Heart, Lung, and Blood Institute (NHLBI)

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:

ROC Public Homepage This link exits the ClinicalTrials.gov site

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:	September 21, 2011
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
Ventricular Fibrillation
Tachycardia, Ventricular
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Amiodarone
Lidocaine
Anti-Arrhythmia Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 21, 2012