- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401647
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS)
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada
- University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
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Toronto, Ontario, Canada
- Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
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Alabama
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Birmingham, Alabama, United States, 35294
- Alabama Resuscitation Center
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California
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San Diego, California, United States, 92103
- UCSD-San Diego Resuscitation Center
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Oregon
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Portland, Oregon, United States, 97239
- Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- The Pittsburgh Resuscitation Network, University of Pittsburgh
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Texas
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Dallas, Texas, United States, 75390
- Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
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Washington
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Seattle, Washington, United States, 98195
- Seattle-King County Center for Resuscitation Research, University of Washington
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Milwaukee Resuscitation Network, Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Active Comparator: Amiodarone
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
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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:
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Active Comparator: Lidocaine
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
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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:
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Placebo Comparator: Normal saline
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
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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.
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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.
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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.
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Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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
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Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Myron Weisfeldt, MD, Johns Hopkins University
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Arrest
- Ventricular Fibrillation
- Tachycardia
- Out-of-Hospital Cardiac Arrest
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 CYP2D6 Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Potassium Channel Blockers
- Lidocaine
- Amiodarone
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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