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Neurological Outcomes After In-Hospital Cardiac Arrest

Completed
Conditions
Inhospital Cardiac Arrest
Interventions
Other: No intervention
Registration Number
NCT03006484
Lead Sponsor
Asan Medical Center
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
322
Inclusion Criteria
  • Age ≥ 18
  • In-hospital cardiac arrest
  • Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for IHCA
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Exclusion Criteria
  • Neither (CPR) code activation nor neurology consultation
  • Development of IHCA during transition period
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
After PeriodNo interventionPatients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
MortalityDay 0-28, 3 month, 6 month, and 12 month after IHCA

A measure of the number of deaths in a particular population

AwakeningDay 0-28 after IHCA

Following commands

CPC scoreDay 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.

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)

Neurological recoveryDay 0-28 after IHCA

CPC of 1

Trial Locations

Locations (1)

Asan Medical Center

🇰🇷

Seoul, Songpa-gu, Korea, Republic of

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