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NCT Number: NCT03006484

Neurological Outcomes After In-Hospital Cardiac Arrest

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.

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Key information

Conditions

Inhospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

About this study

<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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention will be needed.

Primary outcomes

  1. 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.
    • 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)

Secondary outcomes

  1. CPC score

    Time frame: Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after 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.
    • 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)

  2. Mortality

    Time frame: Day 0-28, 3 month, 6 month, and 12 month after IHCA

    A measure of the number of deaths in a particular population

  3. Awakening

    Time frame: Day 0-28 after IHCA

    Following commands

  4. Neurological recovery

    Time frame: Day 0-28 after IHCA

    CPC of 1

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: NO-IHCA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2016
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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