Clinical trial NCT03006484: Neurological Outcomes After In-Hospital Cardiac Arrest
Official title: Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inhospital Cardiac Arrest
Keywords: Cardiac arrest
Inhospital Cardiac Arrest
Cardiopulmonary Resuscitation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient who experienced In-hospital cardiac arrest(IHCA) in 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

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral Performance Category(CPC) score of 1-2
timeFrame: 12 month after In-Hospital Cardiac Arrest(IHCA)
Secondary outcomes:
measure: CPC score
timeFrame: Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA
measure: Mortality
timeFrame: Day 0-28, 3 month, 6 month, and 12 month after IHCA
measure: Awakening
timeFrame: Day 0-28 after IHCA
measure: Neurological recovery
timeFrame: Day 0-28 after IHCA
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Sang-Beom Jeon, Master
role: PRINCIPAL_INVESTIGATOR
References: