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Clinical Trials/NCT03006484
NCT03006484
Completed
Not Applicable

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

Asan Medical Center1 site in 1 country322 target enrollmentMarch 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inhospital Cardiac Arrest
Sponsor
Asan Medical Center
Enrollment
322
Locations
1
Primary Endpoint
Cerebral Performance Category(CPC) score of 1-2
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 21, 2017
End Date
February 3, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sang-Beom Jeon

Associate Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Mortality(Day 0-28, 3 month, 6 month, and 12 month after IHCA)
  • Awakening(Day 0-28 after IHCA)
  • CPC score(Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA)
  • Neurological recovery(Day 0-28 after IHCA)

Study Sites (1)

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