Out-Of-Hospital Cardiac ArrestNCT03695718
Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- How many people
- 1,057 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 3 Dec 2013to 30 Jun 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sustained ROSC from OHCA
Who may be able to join
- Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria:
- Sustained ROSC from OHCA at pre-hospital level
- Sustained ROSC from OHCA at the ED of the participating hospitals after ACLS
- Patients sustained ROSC from OHCA and transferred from other hospital to the ED of the participating hospitals for post-cardiac arrest care
Who cannot join
- Age less than 20 years old
- Patients with advanced directives not to deliver aggressive organ supportive management
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Seoul National University Boramae Hospital
Seoul, 07061
About this study
The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.
Read the detailed description
This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments.
Registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
One year survival
Measured: 1-year
Secondary outcomes (8)
28-day mortality
Mortality on the 28th day
Measured: 28-day
28-day CPC
Brain function at 28th day
Measured: 28-day
6-month CPC
Brain function at 6-month
Measured: 6-month
1-year CPC
Brain function at 1-year
Measured: 1-year
Organ support treatment (mechanical ventilation)
Mechanical ventilation
Measured: Hospital discharge (non-survivors) or 1-year (survivors)
Organ support treatment (renal replacement therapy)
Renal replacement therapy
Measured: Hospital discharge (non-survivors) or 1-year (survivors)
ICU length of stay
ICU length of stay
Measured: Hospital discharge (non-survivors) or 1-year (survivors)
Hospital length of stay
Hospital length of stay
Measured: Hospital discharge (non-survivors) or 1-year (survivors)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start3 Dec 2013
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
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.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,057 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jong Hwan Shin, Seoul National University Hospital
- Investigators
- Jonghwan Shin, MD, PhD, Study director, Seoul National University Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695718
- Sponsor's protocol ID
- 16-2013-157
- Status last verified
- Feb 2022
- First submitted
- 8 Jun 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03695718
- Acronym / sponsor ID
- 16-2013-157
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Oct 2018 (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 aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.
Detailed description
This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments.
Registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sustained ROSC from OHCA
Key inclusion criteria (4 listed)
- Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria:
Key exclusion criteria (2 listed)
- Age less than 20 years old
- Patients with advanced directives not to deliver aggressive organ supportive management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: 1-year
One year survival
8 secondary outcomes
28-day mortality
Time frame: 28-day
28-day CPC
Time frame: 28-day
6-month CPC
Time frame: 6-month
1-year CPC
Time frame: 1-year
Organ support treatment (mechanical ventilation)
Time frame: Hospital discharge (non-survivors) or 1-year (survivors)
Organ support treatment (renal replacement therapy)
Time frame: Hospital discharge (non-survivors) or 1-year (survivors)
ICU length of stay
Time frame: Hospital discharge (non-survivors) or 1-year (survivors)
Hospital length of stay
Time frame: Hospital discharge (non-survivors) or 1-year (survivors)
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 18 Feb 2022.
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Jonghwan Shin, MD, PhD study director
Seoul National University Boramae Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 3 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 4 inclusion and 2 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Survival (time frame: 1-year). 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 18 Feb 2022.