Neurological Outcomes After In-Hospital Cardiac Arrest

NCT ID: NCT03006484

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 322 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-21
• Study Completion Date: 2020-02-03

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

Conditions

Inhospital Cardiac Arrest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Before Period

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

No interventions assigned to this group

After Period

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

No intervention

Intervention Type: OTHER

No intervention will be needed.

Interventions

No intervention

No intervention will be needed.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sang-Beom Jeon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang-Beom Jeon, Master

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

Other Identifiers

2016-1378

Identifier Type: -

Identifier Source: org_study_id