NCT03006484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

December 26, 2016

Last Update Submit

May 12, 2020

Conditions

Inhospital Cardiac Arrest

Keywords

Cardiac arrestInhospital Cardiac ArrestCardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Cerebral Performance Category(CPC) score of 1-2

    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)

    12 month after In-Hospital Cardiac Arrest(IHCA)

Secondary Outcomes (4)

  • CPC score

    Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA

  • Mortality

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

  • Awakening

    Day 0-28 after IHCA

  • Neurological recovery

    Day 0-28 after IHCA

Study Arms (2)

Before Period

Patients who developed in-hosptial cardiac arrest before the implementation of new legislation on life-sustaining treatments

After Period

Patients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments

Other: No intervention

Interventions

No interventionOTHER

No intervention will be needed.

After Period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patient who experienced In-hospital cardiac arrest(IHCA) in Asan Medical Center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sang-Beom Jeon, Master

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 30, 2016

Study Start

March 21, 2017

Primary Completion

February 3, 2020

Study Completion

February 3, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)