Neurological Outcomes After In-Hospital Cardiac Arrest

Inhospital Cardiac Arrest Clinical Trial

— NO-IHCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006484
• Other study ID #: 2016-1378
• Status: Completed
• Start date: March 21, 2017
• Est. completion date: February 3, 2020

Study information

• Verified date: May 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

• 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

• 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

• ACDU(Alert/Confused/Drowsy/Unresponsive) score

• FOUR(Full Outline of Unresponsiveness) score

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Inhospital Cardiac Arrest

Intervention

Other:
• No intervention
No intervention will be needed.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Scale; brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes; motor status; Responsive state: Medical Research Council grade; Unresponsive 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	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 Scale; brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes; motor status; Responsive state: Medical Research Council grade; Unresponsive 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
Secondary	Mortality	A measure of the number of deaths in a particular population	Day 0-28, 3 month, 6 month, and 12 month after IHCA
Secondary	Awakening	Following commands	Day 0-28 after IHCA
Secondary	Neurological recovery	CPC of 1	Day 0-28 after IHCA