AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA
Primary Purpose
Out-of-Hospital Cardiac Arrest
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vasopressins
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Out-of-Hospital Cardiac Arrest focused on measuring Out-of-Hospital Cardiac Arrest, Vasopressin
Eligibility Criteria
Inclusion Criteria:
- non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm
Exclusion Criteria:
- OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
- trauma patients
- age < 18 years old
- failed arterial line insertion within 6 minutes after randomization
- Extracorporeal cardiopulmonary resuscitation
- Time interval between arrest and ED arrival > 60 minutes
- ROSC within 6 minutes after ED arrival
- Diastolic Blood Pressure > 20 mmHg during resuscitation
Sites / Locations
- Chonnam National University Hospital
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vasopressins
Normal saline
Arm Description
Additional vasopressin 40 IU intravenous injection for 2 times
Additional normal saline intravenous injection for 2 times
Outcomes
Primary Outcome Measures
Sustained return of spontaneous circulation (ROSC)
CPCR result Achievement of sustained ROSC was declared when patients had a palpable pulse for more than 20 minutes.
Secondary Outcome Measures
Improvement of arterial diastolic blood pressure assessed by arterial line
Successful adult resuscitation is more likely when diastolic blood pressure is > 25 to 30 mmHg.
The 2015 AHA Guidelines for CPR and ECC recommend "trying to improve quality of CPR by optimizing chest compression parameters or giving vasopressors or both" if diastolic blood pressure is <20 mmHg.
Investigators will record the hemodynamic monitor in real-time.
Improvement of end-tidal carbon dioxide concentrations assessed by capnography
End-tidal carbon dioxide concentrations during CPR are primarily dependent on pulmonary blood flow and therefore reflect cardiac output.
Failure to maintain end-tidal carbon dioxide concentrations > 10 mmHg during adult CPR reflects poor cardiac output and strongly predicts unsuccessful resuscitation.
Investigators will record the end-tidal carbon dioxide concentrations in real-time.
Improvement of acid-base status measured by blood-gas analysis
Data are insufficient to make a conclusions, acid-base status can reflect the status of the ischemic insult on a cellular level. The changed of acid-base status during CPR may be associated with outcomes in cardiac arrest patients.
Improvement of lactate level measured by blood-gas analysis
In previous studies, low lactate level was prognostic factors for favourable outcome after sustained ROSC.
Lactate level can reflect the status of the ischemic insult on a cellular level.
Low level of neuron specific enolase level
Low level of neuron specific enolase level is known as a prognostic indicator of neurologic outcome after cardiac arrest.
Good neurological outcome based on Cerebral Performance Categories Scale
CPC 1. Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit. CPC 2. Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. CPC 3. Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. CPC 4. Coma or vegetative state: any degree of coma without the presence of all brain death criteria. CPC 5. Brain death: apnea, areflexia, EEG silence, etc.
Good neurologic outcome is defined as CPC 1 and 2.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03191240
Brief Title
AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA
Official Title
AMCPR (Augmented-Medication CardioPulmonary Resuscitation) for Improving Outcome in Patient With Cardiac Arrest: Multi-center, Double-blind, Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 31, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary Resuscitation: administration of additional vasopressin to titrate to arterial diastolic blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in out-of-hospital cardiac arrest patients.
Detailed Description
Non-traumatic out-of-hospital cardiac arrest patients receive standard advanced cardiac life support according to the 2015 AHA guideline, including chest compression, intubation, ventilation, defibrillation, drug administration, including epinephrine and antiarrhythmic drugs if indicated, in the emergency department.
A research associate generates a random sequence using Excel software, and assignment of participants to their respective groups will be undertaken by the principal investigator.
Arterial line insertion is performed within 6 minutes after randomization and diastolic blood pressure will be monitored.
If diastolic blood pressure is < 20 mmHg, drugs (vasopressin 40 IU or normal saline) will be administered for two times during CPR.
Arterial blood gas analysis will be analyzed for 5, 10, 15, and 20 minutes after arterial line insertion or termination of CPR.
End-tidal carbon dioxide concentrations is monitored in real time during CPR and recorded every minute.
The resuscitated patients receive standard post cardiac arrest care according to the 2015 AHA guideline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest
Keywords
Out-of-Hospital Cardiac Arrest, Vasopressin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vasopressins
Arm Type
Experimental
Arm Description
Additional vasopressin 40 IU intravenous injection for 2 times
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Additional normal saline intravenous injection for 2 times
Intervention Type
Drug
Intervention Name(s)
Vasopressins
Other Intervention Name(s)
Vasopressin inj
Intervention Description
Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Sustained return of spontaneous circulation (ROSC)
Description
CPCR result Achievement of sustained ROSC was declared when patients had a palpable pulse for more than 20 minutes.
Time Frame
for 20 minutes after the time that participants had a palpable pulse
Secondary Outcome Measure Information:
Title
Improvement of arterial diastolic blood pressure assessed by arterial line
Description
Successful adult resuscitation is more likely when diastolic blood pressure is > 25 to 30 mmHg.
The 2015 AHA Guidelines for CPR and ECC recommend "trying to improve quality of CPR by optimizing chest compression parameters or giving vasopressors or both" if diastolic blood pressure is <20 mmHg.
Investigators will record the hemodynamic monitor in real-time.
Time Frame
during CPR, every 10 seconds after arterial line insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes
Title
Improvement of end-tidal carbon dioxide concentrations assessed by capnography
Description
End-tidal carbon dioxide concentrations during CPR are primarily dependent on pulmonary blood flow and therefore reflect cardiac output.
Failure to maintain end-tidal carbon dioxide concentrations > 10 mmHg during adult CPR reflects poor cardiac output and strongly predicts unsuccessful resuscitation.
Investigators will record the end-tidal carbon dioxide concentrations in real-time.
Time Frame
during CPR, every one minute after endotracheal tube insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes
Title
Improvement of acid-base status measured by blood-gas analysis
Description
Data are insufficient to make a conclusions, acid-base status can reflect the status of the ischemic insult on a cellular level. The changed of acid-base status during CPR may be associated with outcomes in cardiac arrest patients.
Time Frame
during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR
Title
Improvement of lactate level measured by blood-gas analysis
Description
In previous studies, low lactate level was prognostic factors for favourable outcome after sustained ROSC.
Lactate level can reflect the status of the ischemic insult on a cellular level.
Time Frame
during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR
Title
Low level of neuron specific enolase level
Description
Low level of neuron specific enolase level is known as a prognostic indicator of neurologic outcome after cardiac arrest.
Time Frame
24, 48, and 72 hours after ROSC
Title
Good neurological outcome based on Cerebral Performance Categories Scale
Description
CPC 1. Good cerebral performance: conscious, alert, able to work, might have mild neurologic or psychologic deficit. CPC 2. Moderate cerebral disability: conscious, sufficient cerebral function for independent activities of daily life. CPC 3. Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. CPC 4. Coma or vegetative state: any degree of coma without the presence of all brain death criteria. CPC 5. Brain death: apnea, areflexia, EEG silence, etc.
Good neurologic outcome is defined as CPC 1 and 2.
Time Frame
checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm
Exclusion Criteria:
OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
trauma patients
age < 18 years old
failed arterial line insertion within 6 minutes after randomization
Extracorporeal cardiopulmonary resuscitation
Time interval between arrest and ED arrival > 60 minutes
ROSC within 6 minutes after ED arrival
Diastolic Blood Pressure > 20 mmHg during resuscitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Young Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA
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