AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03191240

Collaborator

(none)

110

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Out-of-Hospital Cardiac Arrest	Drug: Vasopressins Drug: Normal saline	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

AMCPR (Augmented-Medication CardioPulmonary Resuscitation) for Improving Outcome in Patient With Cardiac Arrest: Multi-center, Double-blind, Prospective Randomized Clinical Trial.

Actual Study Start Date :

Dec 31, 2017

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vasopressins Additional vasopressin 40 IU intravenous injection for 2 times	Drug: Vasopressins Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation Other Names: Vasopressin inj
Placebo Comparator: Normal saline Additional normal saline intravenous injection for 2 times	Drug: Normal saline Placebo Other Names: 0.9% sodium chloride

Arm

Intervention/Treatment

Experimental: Vasopressins

Additional vasopressin 40 IU intravenous injection for 2 times

Drug: Vasopressins

Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation

Other Names:

Vasopressin inj

Placebo Comparator: Normal saline

Additional normal saline intravenous injection for 2 times

Drug: Normal saline

Placebo

Other Names:

0.9% sodium chloride

Outcome Measures

Primary Outcome Measures

Sustained return of spontaneous circulation (ROSC) [for 20 minutes after the time that participants had a palpable pulse]
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 [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]
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 [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]
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 [during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR]
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 [during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR]
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 [24, 48, and 72 hours after ROSC]
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 [checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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