Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Washington
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: February 25, 2016
Last verified: February 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Arrest |
Drug: amiodarone Drug: Lidocaine Other: Normal saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) |
Resource links provided by NLM:
Drug Information available for:
Lidocaine hydrochloride
Lidocaine
Amiodarone
Amiodarone hydrochloride
U.S. FDA Resources
Further study details as provided by University of Washington:
Primary Outcome Measures:
- Survival to hospital discharge [ Time Frame: Patients will be followed from the time of the CA until death in the field, ED or hospital, or hospital discharge, whichever occurs first. The longest estimated period for the outcome measure assessment is 6 months from the date of the event CA. ] [ Designated as safety issue: No ]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. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months or more.
Secondary Outcome Measures:
- The secondary endpoint of the trial is survival to discharge with a Modified Rankin Score (MRS) ≤ 3 and will be compared in patients randomized to PM101 versus placebo, lidocaine versus placebo, and PM101 versus lidocaine in the efficacy population. [ Time Frame: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first. ] [ Designated as safety issue: Yes ]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. There is no average time frame for the hospitalization period as it may be less than one day or it can last 3-6 months.
| Estimated Enrollment: | 3000 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2016 |
| Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Amiodarone
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
|
Drug: 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.
Other Name: PM 101, Nexterone
|
|
Active Comparator: Lidocaine
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
|
Drug: 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.
Other Name: lidocaine hydrochloride
|
|
Placebo Comparator: Normal saline
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
|
Other: 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.
|
Detailed Description:
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:
- Lidocaine compared to placebo
- PM101 compared to lidocaine The corresponding null hypotheses are that survival to hospital admission is identically distributed when out-of-hospital VF/VT arrest is treated with lidocaine as compared with placebo, and with PM101 as compared with lidocaine.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401647
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401647
Locations
| United States, Alabama | |
| Alabama Resuscitation Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCSD-San Diego Resuscitation Center | |
| San Diego, California, United States, 92103 | |
| United States, Oregon | |
| Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Texas | |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| United States, Washington | |
| Seattle-King County Center for Resuscitation Research, University of Washington | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Ontario | |
| 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 | |
Sponsors and Collaborators
University of Washington
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
Investigators
| Study Chair: | Myron Weisfeldt, MD | Johns Hopkins University |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susanne May, ROC Principal Investigator, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01401647 History of Changes |
| Other Study ID Numbers: | 40605-B 5U01HL077863-07 |
| Study First Received: | July 8, 2011 |
| Last Updated: | February 25, 2016 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by University of Washington:
|
cardiac arrest cardiopulmonary resuscitation ventricular fibrillation pulseless ventricular tachycardia Non-traumatic Out of Hospital Cardiac Arrest (OOHCA) |
Additional relevant MeSH terms:
|
Heart Arrest Tachycardia Tachycardia, Ventricular Out-of-Hospital Cardiac Arrest Ventricular Fibrillation Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Lidocaine Amiodarone Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Potassium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors |
ClinicalTrials.gov processed this record on September 29, 2016