Out-of-Hospital Cardiac ArrestNCT03615300
Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL
An observational study of Out-of-Hospital Cardiac Arrest, run by Uijeongbu St. Mary Hospital at 1 site in South Korea.
Trial summary
This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months. 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?
- serum NGAL
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2018to 1 May 2022
- 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: Adult survivors after out-of-hopital cardiac arrest who underwent targeted temperature management and survived longer than 3 days.
Who may be able to join
- Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest.
Who cannot join
- Patients who did not survived 3 days after cardiac arrest.
- Pre-existing end-stage renal disease or dependence on renal replacement therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
About this study
Official title: Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL: A Prospective, Observational Study
This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.
Read the detailed description
Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- serum NGAL
- 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.
serum NGALDiagnostic test
serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.
| Study group | Role | What they receive |
|---|---|---|
| good neurologic outcome | Patients with good neurological prognosis after 6 months (CPC 1, 2). serum NGAL is collected. Receives: Diagnostic Test: serum NGAL | |
| poor neurologic outcome | Patients with poor neurological prognosis after 6 months (CPC 3, 4, 5). serum NGAL is collected. Receives: Diagnostic Test: serum NGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term neurologic outcome
Patients' CPC score after 6 months (good outcome : CPC score 1, 2 / poor outcome : CPC score 3, 4, 5)
Measured: 6 months
Secondary outcomes (1)
Proportion of participants with Overall Survival at 6 months
6-month survival rate of patients'
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start28 Jun 2018
- Primary completion1 May 2022
- Study completion1 May 2022
Why it stopped: Recruiting unavailable
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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uijeongbu St. Mary Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo Suk Oh, MD. PhD., Uijeongbu St. Mary Hospital
- Investigators
- Joo Suk Oh, MD PhD, Principal investigator, The Catholic University of Korea, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615300
- Sponsor's protocol ID
- UC18OESI0055
- Status last verified
- May 2024
- First submitted
- 30 Jul 2018
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elmer J, Jeong K, Abebe KZ, Guyette FX, Murugan R, Callaway CW, Rittenberger JC; Pittsburgh Post-Cardiac Arrest Service. Serum Neutrophil Gelatinase-Associated Lipocalin Predicts Survival After Resuscitation From Cardiac Arrest. Crit Care Med. 2016 Jan;44(1):111-9. doi: 10.1097/CCM.0000000000001357.
PubMed 26457752Park YR, Oh JS, Jeong H, Park J, Oh YM, Choi S, Choi KH. Predicting long-term outcomes after cardiac arrest by using serum neutrophil gelatinase-associated lipocalin. Am J Emerg Med. 2018 Apr;36(4):660-664. doi: 10.1016/j.ajem.2017.12.013. Epub 2017 Dec 7.
PubMed 29317152
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03615300
- Acronym / sponsor ID
- UC18OESI0055
- Conditions
- Out-of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruiting unavailable
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Uijeongbu St. Mary HospitalUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Aug 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.
This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.
Detailed description
Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good neurologic outcome | – | Diagnostic Test: serum NGALPatients with good neurological prognosis after 6 months (CPC 1, 2). serum NGAL is collected. |
| poor neurologic outcome | – | Diagnostic Test: serum NGALPatients with poor neurological prognosis after 6 months (CPC 3, 4, 5). serum NGAL is collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult survivors after out-of-hopital cardiac arrest who underwent targeted temperature management and survived longer than 3 days.
Key inclusion criteria (1 listed)
- Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest.
Key exclusion criteria (2 listed)
- Patients who did not survived 3 days after cardiac arrest.
- Pre-existing end-stage renal disease or dependence on renal replacement therapy
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 |
|---|---|---|
| serum NGALserum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation. | Diagnostic test | good neurologic outcome, poor neurologic outcome |
Primary outcome
Long term neurologic outcome
Time frame: 6 months
Patients' CPC score after 6 months (good outcome : CPC score 1, 2 / poor outcome : CPC score 3, 4, 5)
1 secondary outcome
Proportion of participants with Overall Survival at 6 months
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruiting unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 26457752Elmer J, Jeong K, Abebe KZ, Guyette FX, Murugan R, Callaway CW, Rittenberger JC; Pittsburgh Post-Cardiac Arrest Service. Serum Neutrophil Gelatinase-Associated Lipocalin Predicts Survival After Resuscitation From Cardiac Arrest. Crit Care Med. 2016 Jan;44(1):111-9. doi: 10.1097/CCM.0000000000001357.
- Results publication: PubMed 29317152Park YR, Oh JS, Jeong H, Park J, Oh YM, Choi S, Choi KH. Predicting long-term outcomes after cardiac arrest by using serum neutrophil gelatinase-associated lipocalin. Am J Emerg Med. 2018 Apr;36(4):660-664. doi: 10.1016/j.ajem.2017.12.013. Epub 2017 Dec 7.
- Individual participant dataSharing planned: No
Related trials for Out-of-Hospital Cardiac Arrest
Active, not recruiting
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Cardiac Arrest, Out-Of-Hospital
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
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Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
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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.
Joo Suk Oh, MD PhD principal investigator
The Catholic University of Korea, Uijeongbu 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?
An observational study of Out-of-Hospital Cardiac Arrest, run by Uijeongbu St. Mary Hospital 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 1 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: stopped early, as of the sponsor's last update on 13 May 2024. 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?
The study was stopped early (reason given: Recruiting unavailable). Results are not available in the source record.
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?
Long term neurologic outcome (time frame: 6 months). 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 NCT03615300, 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 13 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.