Neurological Outcomes After In-Hospital Cardiac Arrest (NO-IHCA)

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

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.

Study Overview

• Status: Completed
• Conditions: Inhospital Cardiac Arrest
• Intervention / Treatment: Other: No intervention

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

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention will be needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.mental status: ACDU score, FOUR score and Glasgow Coma Scalebrain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexesmotor statusResponsive state: Medical Research Council gradeUnresponsive state: motor response to painful stimuli)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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPC score	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.mental status: ACDU score, FOUR score and Glasgow Coma Scalebrain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexesmotor statusResponsive state: Medical Research Council gradeUnresponsive state: motor response to painful stimuli)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)	Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA
Mortality	A measure of the number of deaths in a particular population	Day 0-28, 3 month, 6 month, and 12 month after IHCA
Awakening	Following commands	Day 0-28 after IHCA
Neurological recovery	CPC of 1	Day 0-28 after IHCA

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Sang-Beom Jeon, Master, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2017
• Primary Completion (ACTUAL): February 3, 2020
• Study Completion (ACTUAL): February 3, 2020

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (ESTIMATE): December 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac arrest; Cardiopulmonary Resuscitation; Inhospital Cardiac Arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2016-1378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO