Post Cardiac Arrest Patient Who Was Treated by Hypothermia ProtocolNCT01987466
Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
An observational study of Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol, run by Yonsei University at 1 site in South Korea.
Trial summary
Postresuscitation disease is a constellation of disorders related to whole-body ischemia and reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other organ. In previous study more than one-third of patients resuscitation from out of hospital cardiac arrest developed renal dysfunction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
- What is being tested?
- Serum NGAL level
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Oct 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 19 years of age admitted to our hospital after succesful resuscitation from out of hospital cardiac arrest. Mental state of the patient is less than 8 in GCS scale and the patient should be undergoing therapeutic hypothermia.Exclusion criteria is age younger than 19 years, terminal illness or do-not resuscitation status, pre-existing coma, abnormal mental status with defined intracranial lesion (ex. cerebral hemorrhage, cerebral infarction, etc), unstable vital sign and previous end-stage renal disease.
Who may be able to join
- 19 years and older
- Successful resuscitation from out of hospital cardiac arrest and spontaneous circulation time is longer than 20 min.
- GCS < 8
Who cannot join
- Pre-existing coma before cardiac arrest
- Mental change with other cause except cardiac arrest.(Ex. traumatic brain injury, cerebro-vascular accident.)
- Unstable vital sign (Systolic blood pressure is lower than 60mmHg)
- History of terminal illness.
- Coagulation deficiency.
- Pregnancy state or younger than 18 year
Show all 11Show fewer
- Pre-existing end-stage renal disease or dependence on renal replacement therapy
- Transfer to other hospital and cannot know prognosis
- Withdrawal of care due to family wishes
- The patient arrives our hospital after 4 hours or longer from resuscitation.
- The patient refuses to sign the consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Emergency Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752
Yoo Seok Park, MD, 82-2-2228-2460, pys0905@yuhs.ac
About this study
Postresuscitation disease is a constellation of disorders related to whole-body ischemia and reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other organ. In previous study more than one-third of patients resuscitation from out of hospital cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker compared with serum creatinine.
Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.
This study was designed to assess serum NGAL level in postresuscitative patients to evaluate its relation to hypoxic brain injury severity, and its clinical utility for early detection of acute kidney injury in these patients.
- Being tested
- Serum NGAL level
- Keywords
- Neutrophil Gelatinase-associated Lipocalin(NGAL), Acute renal failure, Cardiac arrest, Hypothermia
- Medical subject headings
- Acute Kidney Injury, Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum NGAL levelBiological
Investigators will check the plasma NGAL level after 4 hour from resuscitation. The plasma NGAL level is measured in ng/mg
| Study group | Role | What they receive |
|---|---|---|
| Post cardiac arrest patient | Not described Receives: Biological: Serum NGAL level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.
All patients in this study will be treated by induced hypothermia protocol in our hospital. Plasma NGAL level will check after 4hour from resuscitation. Renal dysfunction is defined using the RIFLE criteria. Patient base line creatinine is defined the first laboratory values obtained in the emergency department. The maximum difference between the peak creatinine level during the first 72hour of hospitalization and the base line creatinine level was determined for every patients.
Cerebral dysfunction is defined using CPC scale. Neurologic exam will be performed on arrival, 24, 48,72 hours after resuscitation and discharge day. Good neurologic outcome is defined as CPC of 1 or 2. The diagnostic accuracy of NGAL in predicting acute kidney injury and neurologic outcome will be evaluated.
Measured: Every 4 hour until 72 hour after resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Cardiac Arrest Patient Who Was Treated by Hypothermia ProtocolStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987466
- Sponsor's protocol ID
- 4-2013-0575
- Status last verified
- Nov 2013
- First submitted
- 12 Nov 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JH, Park I, You JS, Kim MJ, Lee HS, Park YS, Park HC, Chung SP. Predictive performance of plasma neutrophil gelatinase-associated lipocalin for neurologic outcomes in out-of-hospital cardiac arrest patients treated with targeted temperature management: A prospective observational study. Medicine (Baltimore). 2019 Aug;98(34):e16930. doi: 10.1097/MD.0000000000016930.
PubMed 31441881
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT01987466
- Acronym / sponsor ID
- 4-2013-0575
- Keywords
- Neutrophil Gelatinase-associated Lipocalin(NGAL), Acute renal failure, Cardiac arrest, Hypothermia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Nov 2013 (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.
Postresuscitation disease is a constellation of disorders related to whole-body ischemia and reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other organ. In previous study more than one-third of patients resuscitation from out of hospital cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker compared with serum creatinine.
Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.
This study was designed to assess serum NGAL level in postresuscitative patients to evaluate its relation to hypoxic brain injury severity, and its clinical utility for early detection of acute kidney injury in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post cardiac arrest patient | – | Biological: Serum NGAL level |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 19 years of age admitted to our hospital after succesful resuscitation from out of hospital cardiac arrest. Mental state of the patient is less than 8 in GCS scale and the patient should be undergoing therapeutic hypothermia.Exclusion criteria is age younger than 19 years, terminal illness or do-not resuscitation status, pre-existing coma, abnormal mental status with defined intracranial lesion (ex. cerebral hemorrhage, cerebral infarction, etc), unstable vital sign and previous end-stage renal disease.
Key inclusion criteria (3 listed)
- 19 years and older
- Successful resuscitation from out of hospital cardiac arrest and spontaneous circulation time is longer than 20 min.
- GCS < 8
Key exclusion criteria (11 listed)
- Pre-existing coma before cardiac arrest
- Mental change with other cause except cardiac arrest.(Ex. traumatic brain injury, cerebro-vascular accident.)
- Unstable vital sign (Systolic blood pressure is lower than 60mmHg)
- History of terminal illness.
- Coagulation deficiency.
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 NGAL levelInvestigators will check the plasma NGAL level after 4 hour from resuscitation. The plasma NGAL level is measured in ng/mg | Biological | Post cardiac arrest patient |
Primary outcome
Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.
Time frame: Every 4 hour until 72 hour after resuscitation
All patients in this study will be treated by induced hypothermia protocol in our hospital. Plasma NGAL level will check after 4hour from resuscitation. Renal dysfunction is defined using the RIFLE criteria. Patient base line creatinine is defined the first laboratory values obtained in the emergency department. The maximum difference between the peak creatinine level during the first 72hour of hospitalization and the base line creatinine level was determined for every patients. Cerebral dysfunction is defined using CPC scale. Neurologic exam will be performed on arrival, 24, 48,72 hours after resuscitation and discharge day. Good neurologic outcome is defined as CPC of 1 or 2. The diagnostic accuracy of NGAL in predicting acute kidney injury and neurologic outcome will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Derived from this study: PubMed 31441881Lee JH, Park I, You JS, Kim MJ, Lee HS, Park YS, Park HC, Chung SP. Predictive performance of plasma neutrophil gelatinase-associated lipocalin for neurologic outcomes in out-of-hospital cardiac arrest patients treated with targeted temperature management: A prospective observational study. Medicine (Baltimore). 2019 Aug;98(34):e16930. doi: 10.1097/MD.0000000000016930.
Related trials for Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
RecruitingObservational study
Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling
Cardiac Arrest (CA), Resuscitated Sudden Cardiac Death
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.
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 Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol, run by Yonsei University 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 3 inclusion and 11 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 19 Nov 2013. 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 Yoo Seok Park, MD (82-2-2228-2460, pys0905@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest. (time frame: Every 4 hour until 72 hour after resuscitation). 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 NCT01987466, which also lists 1 linked publication.
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 19 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.