Clinical trial NCT03191240: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: Out-of-Hospital Cardiac Arrest
Vasopressin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sustained return of spontaneous circulation (ROSC)
timeFrame: for 20 minutes after the time that participants had a palpable pulse
Secondary outcomes:
measure: Improvement of arterial diastolic blood pressure assessed by arterial line
timeFrame: 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
measure: Improvement of end-tidal carbon dioxide concentrations assessed by capnography
timeFrame: 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
measure: Improvement of acid-base status measured by blood-gas analysis
timeFrame: during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR
measure: Improvement of lactate level measured by blood-gas analysis
timeFrame: during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR
measure: Low level of neuron specific enolase level
timeFrame: 24, 48, and 72 hours after ROSC
measure: Good neurological outcome based on Cerebral Performance Categories Scale
timeFrame: checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks)
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Won Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: