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Trial record 21 of 133 for:    "Paroxysmal Ventricular Fibrillation"

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

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ClinicalTrials.gov Identifier: NCT01401647
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : January 30, 2017
Last Update Posted : April 17, 2017
Sponsor:
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
Information provided by (Responsible Party):
Susanne May, University of Washington

Tracking Information
First Submitted Date  ICMJE July 8, 2011
First Posted Date  ICMJE July 25, 2011
Results First Submitted Date  ICMJE December 5, 2016
Results First Posted Date  ICMJE January 30, 2017
Last Update Posted Date April 17, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
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. ]
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.
Change History Complete list of historical versions of study NCT01401647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2011)
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. ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Official Title  ICMJE Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT)
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:

  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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE
  • 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
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Amiodarone
    Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
    Intervention: Drug: amiodarone
  • Active Comparator: Lidocaine
    IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Normal saline
    IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
    Intervention: Other: Normal saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2016)
3024
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2011)
3000
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01401647
Other Study ID Numbers  ICMJE 40605-D
5U01HL077863-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susanne May, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Study Chair: Myron Weisfeldt, MD Johns Hopkins University
PRS Account University of Washington
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP