AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

February 21, 2022 updated by: Won Young Kim, Asan Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
for 20 minutes after the time that participants had a palpable pulse

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR
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.
24, 48, and 72 hours after ROSC
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.
checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asan Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Won Young Kim, MD, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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