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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
amiodarone
Lidocaine
Normal saline
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, cardiopulmonary resuscitation, ventricular fibrillation, pulseless ventricular tachycardia, Non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Resuscitation Center
  • UCSD-San Diego Resuscitation Center
  • Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
  • The Pittsburgh Resuscitation Network, University of Pittsburgh
  • Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
  • Seattle-King County Center for Resuscitation Research, University of Washington
  • Milwaukee Resuscitation Network, Medical College of Wisconsin
  • University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
  • Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Amiodarone

Lidocaine

Normal saline

Arm Description

Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.

IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.

IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.

Outcomes

Primary Outcome Measures

Number of Participants Who Survive From the Time of Cardiac Arrest 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.

Secondary Outcome Measures

Number of Participants Scoring at or Below a 3 on the MRS Scale
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

Full Information

First Posted
July 8, 2011
Last Updated
March 18, 2017
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 Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01401647
Brief Title
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Acronym
ALPS
Official Title
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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 Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, cardiopulmonary resuscitation, ventricular fibrillation, pulseless ventricular tachycardia, Non-traumatic Out of Hospital Cardiac Arrest (OOHCA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3024 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amiodarone
Arm Type
Active Comparator
Arm Description
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Intervention Type
Drug
Intervention Name(s)
amiodarone
Other Intervention Name(s)
PM 101, Nexterone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
lidocaine hydrochloride
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Description
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.
Time Frame
Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
Secondary Outcome Measure Information:
Title
Number of Participants Scoring at or Below a 3 on the MRS Scale
Description
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
Time Frame
Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myron Weisfeldt, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Resuscitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD-San Diego Resuscitation Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Pittsburgh Resuscitation Network, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Seattle-King County Center for Resuscitation Research, University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Milwaukee Resuscitation Network, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28904070
Citation
Kudenchuk PJ, Leroux BG, Daya M, Rea T, Vaillancourt C, Morrison LJ, Callaway CW, Christenson J, Ornato JP, Dunford JV, Wittwer L, Weisfeldt ML, Aufderheide TP, Vilke GM, Idris AH, Stiell IG, Colella MR, Kayea T, Egan D, Desvigne-Nickens P, Gray P, Gray R, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators. Antiarrhythmic Drugs for Nonshockable-Turned-Shockable Out-of-Hospital Cardiac Arrest: The ALPS Study (Amiodarone, Lidocaine, or Placebo). Circulation. 2017 Nov 28;136(22):2119-2131. doi: 10.1161/CIRCULATIONAHA.117.028624. Epub 2017 Sep 13.
Results Reference
derived
PubMed Identifier
27043165
Citation
Kudenchuk PJ, Brown SP, Daya M, Rea T, Nichol G, Morrison LJ, Leroux B, Vaillancourt C, Wittwer L, Callaway CW, Christenson J, Egan D, Ornato JP, Weisfeldt ML, Stiell IG, Idris AH, Aufderheide TP, Dunford JV, Colella MR, Vilke GM, Brienza AM, Desvigne-Nickens P, Gray PC, Gray R, Seals N, Straight R, Dorian P; Resuscitation Outcomes Consortium Investigators. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2016 May 5;374(18):1711-22. doi: 10.1056/NEJMoa1514204. Epub 2016 Apr 4.
Results Reference
derived
Links:
URL
http://roc.uwctc.org
Description
ROC Public Homepage

Learn more about this trial

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

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