Out-of-hospital Cardiac ArrestPhase 2NCT02790164
Continuous NMB in PCAS
A Phase 2 study testing Esmeron and Saline in people with Out-of-hospital Cardiac Arrest, run by Chun Song Youn at 1 site in South Korea.
Trial summary
The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- Esmeron and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Nov 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (older than 19)
- OHCA with sustained ROSC
- Comatose (i.e., not following commands) following ROSC
- Undergoing targeted temperature management (TTM)
- Time of enrollment ≤ 6hrs from ROSC
Who cannot join
- Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3)
- Traumatic etiology for cardiac arrest
- Protected population (pregnant, prisoner)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial
The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- Esmeron, Saline
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmeronDrug
Also called Rocuronium
Neuromuscular Blockade
SalineDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Experimental | Patients will receive a bolus dose of 0.6 mg/kg, then a continuous I.V. infusion of 0.3-0.6 mg/kg/hr as per standard intensive care unit practice. Receives: Drug: Esmeron |
| Usual Care | Placebo comparator | Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate levels 24 hours after initiation of study drug
Measured: 24 hours
Secondary outcomes (4)
Lactate change over time
Measured: 0, 12, 24, 36 hrs
Survival
in-hospital survival
Measured: Duration of hospitalization, limit 180 days
Good neurological outcome
Modified Rankin Scale
Measured: Duration of hospitalization, limit 180 days
Length of intensive care unit stay
Measured: Duration of ICU stay, limit 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chun Song Youn
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Chonnam National University Hospital, Asan Medical Center, Hanil General Hospital, Ulsan Universty Hospital, Hanyang University Guri Hospital
- Responsible party
- Sponsor-investigator, Chun Song Youn, Seoul St. Mary's Hospital
- Investigators
- Chun Song Youn, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790164
- Sponsor's protocol ID
- 5-2016-B0001-00003
- Status last verified
- Dec 2016
- First submitted
- 25 May 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02790164
- Acronym / sponsor ID
- 5-2016-B0001-00003
- Conditions
- Out-of-hospital Cardiac Arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Chun Song YounUniversity, hospital or other
- Collaborators
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital, Chonnam National University Hospital, Asan Medical Center, Hanil General Hospital, Ulsan Universty Hospital, Hanyang University Guri Hospital
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- 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 main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Experimental | Drug: EsmeronPatients will receive a bolus dose of 0.6 mg/kg, then a continuous I.V. infusion of 0.3-0.6 mg/kg/hr as per standard intensive care unit practice. |
| Usual Care | Placebo comparator | Drug: SalinePatients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (older than 19)
- OHCA with sustained ROSC
- Comatose (i.e., not following commands) following ROSC
- Undergoing targeted temperature management (TTM)
- Time of enrollment ≤ 6hrs from ROSC
Key exclusion criteria (3 listed)
- Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3)
- Traumatic etiology for cardiac arrest
- Protected population (pregnant, prisoner)
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 |
|---|---|---|
| EsmeronAlso: RocuroniumNeuromuscular Blockade | Drug | Rocuronium |
| SalineNormal Saline | Drug | Usual Care |
Primary outcome
Lactate levels 24 hours after initiation of study drug
Time frame: 24 hours
4 secondary outcomes
Lactate change over time
Time frame: 0, 12, 24, 36 hrs
Survival
Time frame: Duration of hospitalization, limit 180 days
Good neurological outcome
Time frame: Duration of hospitalization, limit 180 days
Length of intensive care unit stay
Time frame: Duration of ICU stay, limit 180 days
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 7 Dec 2016.
Related trials for Out-of-hospital Cardiac Arrest
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Active, not recruitingObservational study
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
Wounds and Injuries, Out-of-Hospital Cardiac Arrest
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.
Chun Song Youn, MD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esmeron and Saline in people with Out-of-hospital Cardiac Arrest, run by Chun Song Youn at 1 site 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 5 inclusion and 3 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Lactate levels 24 hours after initiation of study drug (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2016; AzTrials last refreshed its copy on 30 Oct 2026.