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NCT Number: NCT03191240

AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Arrest Heart Diseases Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hospital, Gwangju, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasopressins

Drug

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

Other names: Vasopressin inj

normal saline

Drug

Placebo

Other names: 0.9% sodium chloride

Primary outcomes

  1. Sustained return of spontaneous circulation (ROSC)

    Time frame: 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 outcomes

  1. Improvement of arterial diastolic blood pressure assessed by arterial line

    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

    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.

  2. Improvement of end-tidal carbon dioxide concentrations assessed by capnography

    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

    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.

  3. Improvement of acid-base status measured by blood-gas analysis

    Time frame: 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.

  4. Improvement of lactate level measured by blood-gas analysis

    Time frame: 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.

  5. Low level of neuron specific enolase level

    Time frame: 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.

  6. Good neurological outcome based on Cerebral Performance Categories Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2017
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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