AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

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

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.

Study Overview

• Status: Completed
• Conditions: Out-of-Hospital Cardiac Arrest
• Intervention / Treatment: Drug: Normal saline; Drug: Vasopressins

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of, 05505
    • ASAN Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Won Young Kim, MD, PhD, ASAN Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Vasopressin; Out-of-Hospital Cardiac Arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: AMCPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No