Out-of-Hospital Cardiac ArrestNCT02827422
A Prospective, Multicenter Registry With Targeted Temperature Management After Out-of-hospital Cardiac Arrest in Korea
An observational study of Out-of-Hospital Cardiac Arrest, run by Kyu Nam Park at 1 site in South Korea.
Trial summary
Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. 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?
- not provided
- How many people
- 1,800 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jun 2019
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with therapeutic hypothermia after out-of-hospital cardiac arrest.
Who may be able to join
- age of older than 18 years
- out-of-hospital cardiac arrest
- comatose mentality after return of spontaneous circulation (ROSC)
- treated with therapeutic hypothermia, regardless of target temperature
Who cannot join
- suspected or confirmed to cerebrovascular accident
- poor pre-arrest neurologic status (CPC>3)
- patients who are terminally ill or for whom intensive care dose not seem to be appropriate
- Do not attempt resuscitation (DNAR) order
- patients with tympanic membrane temperature below 30 degree celsius on admission
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
Kyu Nam Park, MD, PhD, 82-2-2258-6301, emsky@catholic.ac.kr
Ji Hoon Kim, MD, PhD
About this study
Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. The objective of this project is to improve the outcomes for patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic hypothermia established from the analysis of multicenter registry data.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- not provided
- Keywords
- therapeutic hypothermia
- 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.
not providedOther
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: 6 months after cardiac arrest
Neurologic Outcome
Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome
Measured: 6 months after cardiac arrest
Neurologic Outcome
modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome
Measured: after 6 months
Secondary outcomes (6)
survival
Measured: duration of hospitalization, limit 180 days
neurological outcome
Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome
Measured: duration of hospitalization, limit 180 days
neurological outcome
modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome
Measured: duration of hospitalization, limit 180 days
Survival
Measured: 1 month after cardiac arrest
neurological outcome
Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome
Measured: 1 month after cardiac arrest
neurological outcome
modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome
Measured: 1 month after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
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.
- 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
- 1,800 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kyu Nam Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyu Nam Park, Seoul St. Mary's Hospital
- Investigators
- Kyu Nam Park, MD. PhD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827422
- Sponsor's protocol ID
- 2015-P33001-00
- Status last verified
- Oct 2016
- First submitted
- 5 Jul 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim YJ, Kim YH, Youn CS, Cho IS, Kim SJ, Wee JH, Park YS, Oh JS, Lee BK, Kim WY. Different neuroprognostication thresholds of neuron-specific enolase in shockable and non-shockable out-of-hospital cardiac arrest: a prospective multicenter observational study in Korea (the KORHN-PRO registry). Crit Care. 2023 Aug 9;27(1):313. doi: 10.1186/s13054-023-04603-6.
PubMed 37559163Oh JH, Lee DH, Cho IS, Youn CS, Lee BK, Wee JH, Cha KC, Chae MK, Shin J; Korean Hypothermia Network Investigators. Association between acute kidney injury and neurological outcome or death at 6 months in out-of-hospital cardiac arrest: A prospective, multicenter, observational cohort study. J Crit Care. 2019 Dec;54:197-204. doi: 10.1016/j.jcrc.2019.08.029. Epub 2019 Aug 28.
PubMed 31521016
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Registry With Targeted Temperature Management After Out-of-hospital Cardiac Arrest in Korea
- ClinicalTrials.gov ID
- NCT02827422
- Acronym / sponsor ID
- 2015-P33001-00
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- therapeutic hypothermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Kyu Nam ParkUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 11 Jul 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.
Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. The objective of this project is to improve the outcomes for patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic hypothermia established from the analysis of multicenter registry data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with therapeutic hypothermia after out-of-hospital cardiac arrest.
Key inclusion criteria (4 listed)
- age of older than 18 years
- out-of-hospital cardiac arrest
- comatose mentality after return of spontaneous circulation (ROSC)
- treated with therapeutic hypothermia, regardless of target temperature
Key exclusion criteria (5 listed)
- suspected or confirmed to cerebrovascular accident
- poor pre-arrest neurologic status (CPC>3)
- patients who are terminally ill or for whom intensive care dose not seem to be appropriate
- Do not attempt resuscitation (DNAR) order
- patients with tympanic membrane temperature below 30 degree celsius on admission
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 |
|---|---|---|
| not provided | Other | – |
Primary outcome
survival
Time frame: 6 months after cardiac arrest
Neurologic Outcome
Time frame: 6 months after cardiac arrest
Cerebral Performance Category (CPC). CPC 1,2 : Good Outcome CPC 3,4,5 : Poor Outcome
Neurologic Outcome
Time frame: after 6 months
modified Rankin Scale (mRS) mRS 0,1,2, 3 : Good Outcome mRS 4,5,6 : Poor Outcome
6 secondary outcomes
survival
Time frame: duration of hospitalization, limit 180 days
neurological outcome
Time frame: duration of hospitalization, limit 180 days
neurological outcome
Time frame: duration of hospitalization, limit 180 days
Survival
Time frame: 1 month after cardiac arrest
neurological outcome
Time frame: 1 month after cardiac arrest
neurological outcome
Time frame: 1 month after cardiac arrest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Derived from this study: PubMed 37559163Kim YJ, Kim YH, Youn CS, Cho IS, Kim SJ, Wee JH, Park YS, Oh JS, Lee BK, Kim WY. Different neuroprognostication thresholds of neuron-specific enolase in shockable and non-shockable out-of-hospital cardiac arrest: a prospective multicenter observational study in Korea (the KORHN-PRO registry). Crit Care. 2023 Aug 9;27(1):313. doi: 10.1186/s13054-023-04603-6.
- Derived from this study: PubMed 31521016Oh JH, Lee DH, Cho IS, Youn CS, Lee BK, Wee JH, Cha KC, Chae MK, Shin J; Korean Hypothermia Network Investigators. Association between acute kidney injury and neurological outcome or death at 6 months in out-of-hospital cardiac arrest: A prospective, multicenter, observational cohort study. J Crit Care. 2019 Dec;54:197-204. doi: 10.1016/j.jcrc.2019.08.029. Epub 2019 Aug 28.
- Individual participant dataSharing planned: No
Related trials for Out-of-Hospital Cardiac Arrest
Active, not recruiting
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
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
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
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.
Kyu Nam Park, MD. PhD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
1 site 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 Kyu Nam Park 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Oct 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyu Nam Park, MD, PhD (82-2-2258-6301, emsky@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 6 months after cardiac arrest). The study lists 3 primary outcomes in all. 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 NCT02827422, 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 21 Oct 2016.