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Neurological Outcomes After In-Hospital Cardiac Arrest

Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03006484
Acronym
NO-IHCA
Enrollment
322
Registered
2016-12-30
Start date
2017-03-21
Completion date
2020-02-03
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inhospital Cardiac Arrest

Keywords

Cardiac arrest, Inhospital Cardiac Arrest, Cardiopulmonary Resuscitation

Brief 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. 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

Interventions

OTHERNo intervention

No intervention will be needed.

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 * In-hospital cardiac arrest * Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for IHCA

Exclusion criteria

* Neither (CPR) code activation nor neurology consultation * Development of IHCA during transition period

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Performance Category(CPC) score of 1-212 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)

Secondary

MeasureTime frameDescription
CPC scoreDay 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCACPC 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)
MortalityDay 0-28, 3 month, 6 month, and 12 month after IHCAA measure of the number of deaths in a particular population
AwakeningDay 0-28 after IHCAFollowing commands
Neurological recoveryDay 0-28 after IHCACPC of 1

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026