NCT01401647

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,024

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2017

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

July 8, 2011

Results QC Date

December 5, 2016

Last Update Submit

March 18, 2017

Conditions

Cardiac Arrest

Keywords

cardiac arrestcardiopulmonary resuscitationventricular fibrillationpulseless ventricular tachycardiaNon-traumatic Out of Hospital Cardiac Arrest (OOHCA)

Outcome Measures

Primary Outcomes (1)

  • 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.

    Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.

Secondary Outcomes (1)

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

    Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.

Study Arms (3)

Amiodarone

ACTIVE COMPARATOR

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

Drug: amiodarone

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

Normal saline

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

amiodaroneDRUG

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.

Also known as: PM 101, Nexterone
Amiodarone
LidocaineDRUG

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.

Also known as: lidocaine hydrochloride
Lidocaine
Normal salineOTHER

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.

Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alabama Resuscitation Center

Birmingham, Alabama, 35294, United States

Location

UCSD-San Diego Resuscitation Center

San Diego, California, 92103, United States

Location

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

The Pittsburgh Resuscitation Network, University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Seattle-King County Center for Resuscitation Research, University of Washington

Seattle, Washington, 98195, United States

Location

Milwaukee Resuscitation Network, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research

Ottawa, Ontario, Canada

Location

Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto

Toronto, Ontario, Canada

Location

Related Publications (2)

  • 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.

    PMID: 28904070DERIVED

  • 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.

    PMID: 27043165DERIVED

Related Links

MeSH Terms

Conditions

Heart ArrestVentricular Fibrillation

Interventions

AmiodaroneLidocaineSaline Solution

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Susanne May
Organization
University of Washington, Resuscitation Outcomes Consortium
rochelp@uwctc.org
206-685-1302

Study Officials

  • Myron Weisfeldt, MD

    Johns Hopkins University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Biostatistics

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 25, 2011

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

April 17, 2017

Results First Posted

January 30, 2017

Record last verified: 2017-03

Locations

US(7)CA(2)