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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL077863-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Heart and Stroke Foundation of Canada | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone | Active Comparator | Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation. |
|
| Lidocaine | Active Comparator | IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation. |
|
| Normal saline | Placebo Comparator | IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amiodarone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Scoring at or Below a 3 on the MRS Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myron Weisfeldt, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Resuscitation Center | Birmingham | Alabama | 35294 | United States | ||
| UCSD-San Diego Resuscitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28904070 | Derived | 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. | |
| 27043165 |
| Label | URL |
|---|---|
| ROC Public Homepage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| American Heart Association |
| OTHER |
| Defence Research and Development Canada | INDUSTRY |
| U.S. Army Medical Research and Development Command | FED |
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|
|
| Lidocaine | Drug | 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 | Other | 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. |
|
| Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first. |
| San Diego |
| California |
| 92103 |
| United States |
| Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University | Portland | Oregon | 97239 | United States |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Seattle-King County Center for Resuscitation Research, University of Washington | Seattle | Washington | 98195 | United States |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research | Ottawa | Ontario | Canada |
| Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto | Toronto | Ontario | Canada |
| Derived |
| 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. |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first. |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Scoring at or Below a 3 on the MRS Scale | 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 | MRS as a secondary outcome is not available on all patients that we have survival for. | Posted | Count of Participants | Participants | Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 972 | 515 | 972 | ||
| EG001 | 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. | 0 | 993 | 548 | 993 | ||
| EG002 | 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. | 0 | 1,059 | 476 | 1,059 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypotension requiring vasopressors | Cardiac disorders | Non-systematic Assessment |
| ||
| Rearrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Seizures or potential seizures | Nervous system disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanne May | University of Washington, Resuscitation Outcomes Consortium | 206-685-1302 | rochelp@uwctc.org |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 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. |
| OG002 | 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. |
|
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