Trial Outcomes & Findings for Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (NCT NCT01401647)
NCT ID: NCT01401647
Last Updated: 2017-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3024 participants
Primary outcome timeframe
Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
972
|
993
|
1059
|
|
Overall Study
COMPLETED
|
968
|
985
|
1056
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
1
|
Baseline Characteristics
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia
Baseline characteristics by cohort
| Measure |
Amiodarone
n=972 Participants
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
n=993 Participants
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
n=1059 Participants
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
n=3024 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
63.1 years
STANDARD_DEVIATION 14.6 • n=206 Participants
|
63.5 years
STANDARD_DEVIATION 14.4 • n=157 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=99 Participants
|
177 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
603 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
761 Participants
n=99 Participants
|
816 Participants
n=107 Participants
|
844 Participants
n=206 Participants
|
2421 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
60 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
95 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
288 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
334 Participants
n=99 Participants
|
315 Participants
n=107 Participants
|
340 Participants
n=206 Participants
|
989 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
518 Participants
n=99 Participants
|
559 Participants
n=107 Participants
|
587 Participants
n=206 Participants
|
1664 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.Population: 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.
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.
Outcome measures
| Measure |
Amiodarone
n=968 Participants
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
n=985 Participants
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
n=1056 Participants
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.
|
|---|---|---|---|
|
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
|
237 participants
|
233 participants
|
222 participants
|
SECONDARY outcome
Timeframe: Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.Population: MRS as a secondary outcome is not available on all patients that we have survival for.
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
Outcome measures
| Measure |
Amiodarone
n=965 Participants
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
n=984 Participants
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
n=1055 Participants
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.
|
|---|---|---|---|
|
Number of Participants Scoring at or Below a 3 on the MRS Scale
|
182 Participants
|
172 Participants
|
175 Participants
|
Adverse Events
Amiodarone
Serious events: 0 serious events
Other events: 515 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 548 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 476 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amiodarone
n=972 participants at risk
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
n=993 participants at risk
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
n=1059 participants at risk
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
20.8%
202/972 • 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.
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.
|
21.0%
209/993 • 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.
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.
|
17.4%
184/1059 • 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.
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.
|
|
Cardiac disorders
Hypotension requiring vasopressors
|
12.1%
118/972 • 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.
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.
|
11.5%
114/993 • 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.
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.
|
9.6%
102/1059 • 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.
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.
|
|
Cardiac disorders
Rearrest
|
5.9%
57/972 • 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.
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.
|
7.7%
76/993 • 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.
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.
|
5.7%
60/1059 • 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.
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.
|
|
Nervous system disorders
Seizures or potential seizures
|
3.6%
35/972 • 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.
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.
|
4.9%
49/993 • 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.
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.
|
3.0%
32/1059 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.6%
103/972 • 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.
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.
|
10.1%
100/993 • 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.
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.
|
9.3%
98/1059 • 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.
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.
|
Additional Information
Dr. Susanne May
University of Washington, Resuscitation Outcomes Consortium
Phone: 206-685-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60