Out-of-Hospital Cardiac Arrest Clinical Trial
Official title:
AMCPR (Augmented-Medication CardioPulmonary Resuscitation) for Improving Outcome in Patient With Cardiac Arrest: Multi-center, Double-blind, Prospective Randomized Clinical Trial.
Verified date | February 2022 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | August 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Asan Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | for 20 minutes after the time that participants had a palpable pulse | |
Secondary | 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. |
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 | |
Secondary | 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. |
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 | |
Secondary | 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. | during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR | |
Secondary | 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. |
during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR | |
Secondary | 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. | 24, 48, and 72 hours after ROSC | |
Secondary | 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. |
checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks) |
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