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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 Materiel Command
Information provided by (Responsible Party):
Susanne May, University of Washington

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cardiac Arrest
Interventions Drug: amiodarone
Drug: Lidocaine
Other: Normal saline
Enrollment 3024
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amiodarone Lidocaine Normal Saline
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 972 993 1059
Completed 968 985 1056
Not Completed 4 8 3
Reason Not Completed
Withdrawal by Subject             1             5             2
Lost to Follow-up             3             3             1
Arm/Group Title Amiodarone Lidocaine Normal Saline Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 972 993 1059 3024
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 972 participants 993 participants 1059 participants 3024 participants
64.0  (14.0) 63.4  (14.7) 63.1  (14.6) 63.5  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 972 participants 993 participants 1059 participants 3024 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 972 participants 993 participants 1059 participants 3024 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%
1.Primary Outcome
Title Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.
Arm/Group Title Amiodarone Lidocaine Normal Saline
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 968 985 1056
Measure Type: Number
Unit of Measure: participants
237 233 222
2.Secondary Outcome
Title Number of Participants Scoring at or Below a 3 on the MRS Scale
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
MRS as a secondary outcome is not available on all patients that we have survival for.
Arm/Group Title Amiodarone Lidocaine Normal Saline
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 965 984 1055
Measure Type: Count of Participants
Unit of Measure: Participants
182
  18.9%
172
  17.5%
175
  16.6%
Time Frame Adverse event data were collected from the time a participating agency arrived on scene and up to 24 hours after Emergency Department arrival this results in adverse events reporting for up to 2 days.
Adverse Event Reporting Description The following are commonly observed in patients who experience cardiac arrest or resuscitative efforts, and may or may not be attributable to specific resuscitation therapies. These were monitored and reported but not considered as adverse events of the study intervention. These include, but not limited to: pulmonary edema, airway bleeding, death, Clinical diagnoses of pneumonia, sepsis, cerebral bleeding, stroke, seizures, rearrest, serious rib fractures, and sternal fractures.
 
Arm/Group Title Amiodarone Lidocaine Normal Saline
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Amiodarone Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amiodarone Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/972 (0.00%)   0/993 (0.00%)   0/1059 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amiodarone Lidocaine Normal Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   515/972 (52.98%)   548/993 (55.19%)   476/1059 (44.95%) 
Cardiac disorders       
Hypotension requiring vasopressors *  118/972 (12.14%)  114/993 (11.48%)  102/1059 (9.63%) 
Rearrest *  57/972 (5.86%)  76/993 (7.65%)  60/1059 (5.67%) 
Nervous system disorders       
Seizures or potential seizures *  35/972 (3.60%)  49/993 (4.93%)  32/1059 (3.02%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary Edema *  202/972 (20.78%)  209/993 (21.05%)  184/1059 (17.37%) 
Pneumonia *  103/972 (10.60%)  100/993 (10.07%)  98/1059 (9.25%) 
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: Dr. Susanne May
Organization: University of Washington, Resuscitation Outcomes Consortium
Phone: 206-685-1302
Responsible Party: Susanne May, University of Washington
ClinicalTrials.gov Identifier: NCT01401647     History of Changes
Other Study ID Numbers: 40605-D
5U01HL077863-07 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2011
First Posted: July 25, 2011
Results First Submitted: December 5, 2016
Results First Posted: January 30, 2017
Last Update Posted: April 17, 2017