Out-of-Hospital Cardiac ArrestPhase 2NCT03191240
AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA
A Phase 2 study testing Vasopressins and Normal saline in people with Out-of-Hospital Cardiac Arrest, run by Asan Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Vasopressins and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 31 Dec 2017to 31 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonnam National University Hospital
Gwangju
Asan Medical Center
Seoul, 05505
About this study
Official title: 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.
Read the 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.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Vasopressins, Normal saline
- Keywords
- Out-of-Hospital Cardiac Arrest, Vasopressin
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinsDrug
Also called Vasopressin inj
Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation
Normal salineDrug
Also called 0.9% sodium chloride
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vasopressins | Experimental | Additional vasopressin 40 IU intravenous injection for 2 times Receives: Drug: Vasopressins |
| Normal saline | Placebo comparator | Additional normal saline intravenous injection for 2 times Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for 20 minutes after the time that participants had a palpable pulse
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start31 Dec 2017
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Young Kim, Asan Medical Center
- Investigators
- Won Young Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191240
- Sponsor's protocol ID
- AMCPR
- Status last verified
- Feb 2022
- First submitted
- 13 Jun 2017
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JS, Kim YJ, Hong SI, Kim SM, Chae B, Ryoo SM, Kim WY. Diastolic blood pressures and end tidal carbon dioxides during cardiopulmonary resuscitations and their association with outcomes in adult out-of-hospital cardiac arrest patients: A preplanned secondary analysis of the Augmented Medication CardioPulmonary resuscitation (AMCPR) trial. Resuscitation. 2025 May;210:110537. doi: 10.1016/j.resuscitation.2025.110537. Epub 2025 Feb 12.
PubMed 39952383Oh DK, Kim JS, Ryoo SM, Kim YJ, Kim SM, Hong SI, Chae B, Kim WY. Augmented-Medication CardioPulmonary Resuscitation (AMCPR) trial: a study protocol for a randomized controlled trial. Clin Exp Emerg Med. 2022 Dec;9(4):361-366. doi: 10.15441/ceem.22.367. Epub 2022 Nov 2.
PubMed 36318879
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMCPR (Augmented-Medication CardioPulmonary Resuscitation) for Improving Outcome in Patient With Cardiac Arrest: Multi-center, Double-blind, Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03191240
- Acronym / sponsor ID
- AMCPR
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Out-of-Hospital Cardiac Arrest, Vasopressin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressins | Experimental | Drug: VasopressinsAdditional vasopressin 40 IU intravenous injection for 2 times |
| Normal saline | Placebo comparator | Drug: Normal salineAdditional normal saline intravenous injection for 2 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinsAlso: Vasopressin injAdminister additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation | Drug | Vasopressins |
| Normal salineAlso: 0.9% sodium chloridePlacebo | Drug | Normal saline |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
Low level of neuron specific enolase level
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 39952383Kim JS, Kim YJ, Hong SI, Kim SM, Chae B, Ryoo SM, Kim WY. Diastolic blood pressures and end tidal carbon dioxides during cardiopulmonary resuscitations and their association with outcomes in adult out-of-hospital cardiac arrest patients: A preplanned secondary analysis of the Augmented Medication CardioPulmonary resuscitation (AMCPR) trial. Resuscitation. 2025 May;210:110537. doi: 10.1016/j.resuscitation.2025.110537. Epub 2025 Feb 12.
- Derived from this study: PubMed 36318879Oh DK, Kim JS, Ryoo SM, Kim YJ, Kim SM, Hong SI, Chae B, Kim WY. Augmented-Medication CardioPulmonary Resuscitation (AMCPR) trial: a study protocol for a randomized controlled trial. Clin Exp Emerg Med. 2022 Dec;9(4):361-366. doi: 10.15441/ceem.22.367. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Young Kim, MD, PhD principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vasopressins and Normal saline in people with Out-of-Hospital Cardiac Arrest, run by Asan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained return of spontaneous circulation (ROSC) (time frame: for 20 minutes after the time that participants had a palpable pulse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191240, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.