Inhospital Cardiac ArrestNO-IHCANCT03006484
Neurological Outcomes After In-Hospital Cardiac Arrest
An observational study of Inhospital Cardiac Arrest, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Little is known about the long-term neurological outcomes after in-hospital cardiac arrest (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence rates of survivors with poor neurological status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inhospital Cardiac Arrest
- How many people
- 322 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2017to 3 Feb 2020
- 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: The patient who experienced In-hospital cardiac arrest(IHCA) in Asan Medical Center.
Who may be able to join
- Age ≥ 18
- In-hospital cardiac arrest
- Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for IHCA
Who cannot join
- Neither (CPR) code activation nor neurology consultation
- Development of IHCA during transition period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study
Little is known about the long-term neurological outcomes after in-hospital cardiac arrest (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence rates of survivors with poor neurological status. Currently, withdrawal of care in comatose patients after cardiac arrest is strongly forbidden by law in Korea. However, a new legislation on allowing withdrawal of care will come into effect since early 2018 in Korea. The investigators aim to determine 1) long-term neurological outcomes in patients who developed IHCA, 2) whether early neurological status can predict late neurological status after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes will change since implementation of new legislation on withdrawal of care.
Read the detailed description
<The schedule of assessment>
- Day 0: Neurological examination (First examination will be performed within 2 hours after IHCA)
- Day1 - 7: Neurological examination
- Day7, 14, 21, 28: Neurological examination, CPC score
- Day90: CPC score, survival
- Day180: CPC score, survival
- Day 360: CPC score, survival
<Cerebral Performance Category(CPC) score>
- CPC 1: good cerebral performance
- CPC 2: Moderate cerebral disability(available for independent activities)
- CPC 3: Severe cerebral disability(dependent on others for daily support)
- CPC 4: Coma or vegetative state
- CPC 5: Brain death or death
<Acronyms>
- ACDU(Alert/Confused/Drowsy/Unresponsive) score
- FOUR(Full Outline of Unresponsiveness) score
- Conditions
- Inhospital Cardiac Arrest
- Being tested
- No intervention
- Keywords
- Cardiac arrest, Inhospital Cardiac Arrest, Cardiopulmonary Resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be needed.
| Study group | Role | What they receive |
|---|---|---|
| Before Period | Patients who developed in-hosptial cardiac arrest before the implementation of new legislation on life-sustaining treatments | |
| After Period | Patients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Performance Category(CPC) score of 1-2
CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.
CPC score will be evaluated by neurological examination and the results of other exam.
- Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.
- mental status: ACDU score, FOUR score and Glasgow Coma Scale
- brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes
- motor status
- Responsive state: Medical Research Council grade
- Unresponsive state: motor response to painful stimuli)
- seizure evaluation: status myoclonus , seizure, status epilepticus
- The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)
Measured: 12 month after In-Hospital Cardiac Arrest(IHCA)
Secondary outcomes (4)
CPC score
CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.
CPC score will be evaluated by neurological examination and the results of other exam.
- Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.
- mental status: ACDU score, FOUR score and Glasgow Coma Scale
- brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes
- motor status
- Responsive state: Medical Research Council grade
- Unresponsive state: motor response to painful stimuli)
- seizure evaluation: status myoclonus , seizure, status epilepticus
- The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)
Measured: Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA
Mortality
A measure of the number of deaths in a particular population
Measured: Day 0-28, 3 month, 6 month, and 12 month after IHCA
Awakening
Following commands
Measured: Day 0-28 after IHCA
Neurological recovery
CPC of 1
Measured: Day 0-28 after IHCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start21 Mar 2017
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Beom Jeon, Asan Medical Center
- Investigators
- Sang-Beom Jeon, Master, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006484
- Sponsor's protocol ID
- 2016-1378
- Acronym
- NO-IHCA
- Status last verified
- May 2020
- First submitted
- 26 Dec 2016
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03006484
- Acronym / sponsor ID
- NO-IHCA / 2016-1378
- Conditions
- Inhospital Cardiac Arrest
- Keywords
- Cardiac arrest, Inhospital Cardiac Arrest, Cardiopulmonary Resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 30 Dec 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.
Little is known about the long-term neurological outcomes after in-hospital cardiac arrest (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence rates of survivors with poor neurological status. Currently, withdrawal of care in comatose patients after cardiac arrest is strongly forbidden by law in Korea. However, a new legislation on allowing withdrawal of care will come into effect since early 2018 in Korea. The investigators aim to determine 1) long-term neurological outcomes in patients who developed IHCA, 2) whether early neurological status can predict late neurological status after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes will change since implementation of new legislation on withdrawal of care.
Detailed description
<The schedule of assessment>
- Day 0: Neurological examination (First examination will be performed within 2 hours after IHCA)
- Day1 - 7: Neurological examination
- Day7, 14, 21, 28: Neurological examination, CPC score
- Day90: CPC score, survival
- Day180: CPC score, survival
- Day 360: CPC score, survival
<Cerebral Performance Category(CPC) score>
- CPC 1: good cerebral performance
- CPC 2: Moderate cerebral disability(available for independent activities)
- CPC 3: Severe cerebral disability(dependent on others for daily support)
- CPC 4: Coma or vegetative state
- CPC 5: Brain death or death
<Acronyms>
- ACDU(Alert/Confused/Drowsy/Unresponsive) score
- FOUR(Full Outline of Unresponsiveness) score
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Period | – | –Patients who developed in-hosptial cardiac arrest before the implementation of new legislation on life-sustaining treatments |
| After Period | – | Other: No interventionPatients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient who experienced In-hospital cardiac arrest(IHCA) in Asan Medical Center.
Key inclusion criteria (3 listed)
- Age ≥ 18
- In-hospital cardiac arrest
- Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for IHCA
Key exclusion criteria (2 listed)
- Neither (CPR) code activation nor neurology consultation
- Development of IHCA during transition period
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 |
|---|---|---|
| No interventionNo intervention will be needed. | Other | After Period |
Primary outcome
Cerebral Performance Category(CPC) score of 1-2
Time frame: 12 month after In-Hospital Cardiac Arrest(IHCA)
CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5. CPC score will be evaluated by neurological examination and the results of other exam. * Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed. 1. mental status: ACDU score, FOUR score and Glasgow Coma Scale 2. brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes 3. motor status * Responsive state: Medical Research Council grade * Unresponsive state: motor response to painful stimuli) 4. seizure evaluation: status myoclonus , seizure, status epilepticus * The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)
4 secondary outcomes
CPC score
Time frame: Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA
Mortality
Time frame: Day 0-28, 3 month, 6 month, and 12 month after IHCA
Awakening
Time frame: Day 0-28 after IHCA
Neurological recovery
Time frame: Day 0-28 after IHCA
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 13 May 2020.
- Individual participant dataSharing planned: No
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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.
Sang-Beom Jeon, Master principal investigator
Asan Medical Center
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 Inhospital Cardiac Arrest, run by Asan Medical Center 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 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 13 May 2020. 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 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?
Cerebral Performance Category(CPC) score of 1-2 (time frame: 12 month after In-Hospital Cardiac Arrest(IHCA)). 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 13 May 2020.