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

This study has been completed.
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 Materiel Command
Information provided by (Responsible Party):
Susanne May, University of Washington
ClinicalTrials.gov Identifier:
NCT01401647
First received: July 8, 2011
Last updated: March 18, 2017
Last verified: March 2017
Results First Received: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Cardiac Arrest
Interventions: Drug: amiodarone
Drug: Lidocaine
Other: Normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Amiodarone

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

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.

Lidocaine

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

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.

Normal Saline

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

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.


Participant Flow:   Overall Study
    Amiodarone   Lidocaine   Normal Saline
STARTED   972   993   1059 
COMPLETED   968   985   1056 
NOT COMPLETED   4   8   3 
Withdrawal by Subject                1                5                2 
Lost to Follow-up                3                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Amiodarone

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

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.

Lidocaine

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

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.

Normal Saline

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

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.

Total Total of all reporting groups

Baseline Measures
   Amiodarone   Lidocaine   Normal Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 972   993   1059   3024 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.0  (14.0)   63.4  (14.7)   63.1  (14.6)   63.5  (14.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      211  21.7%      177  17.8%      215  20.3%      603  19.9% 
Male      761  78.3%      816  82.2%      844  79.7%      2421  80.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      4   0.4%      2   0.2%      4   0.4%      10   0.3% 
Asian      18   1.9%      17   1.7%      25   2.4%      60   2.0% 
Native Hawaiian or Other Pacific Islander      3   0.3%      4   0.4%      5   0.5%      12   0.4% 
Black or African American      95   9.8%      96   9.7%      97   9.2%      288   9.5% 
White      334  34.4%      315  31.7%      340  32.1%      989  32.7% 
More than one race      0   0.0%      0   0.0%      1   0.1%      1   0.0% 
Unknown or Not Reported      518  53.3%      559  56.3%      587  55.4%      1664  55.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Susanne May
Organization: University of Washington, Resuscitation Outcomes Consortium
phone: 206-685-1302
e-mail: rochelp@uwctc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Susanne May, University of Washington
ClinicalTrials.gov Identifier: NCT01401647     History of Changes
Other Study ID Numbers: 40605-D
5U01HL077863-07 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2011
Results First Received: December 5, 2016
Last Updated: March 18, 2017