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Clinical Trials/NCT03154879
NCT03154879
Unknown
Not Applicable

Prospective Multi-center Study to Verify Neurological Prognostic Value of Amplitude-integrated Electroencephalogram in Cardiac Arrest Patients Treated With Therapeutic Hypothermia

Seoul St. Mary's Hospital4 sites in 1 country500 target enrollmentJune 1, 2017
ConditionsHeart Arrest

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Arrest
Sponsor
Seoul St. Mary's Hospital
Enrollment
500
Locations
4
Primary Endpoint
Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2
Last Updated
8 years ago

Overview

Brief Summary

The investigators examine the prognostic value of continuous electroencephalography on frontal area of brain according to time by performing amplitude-integrated electroencephalography (aEEG) on cardiac arrest patients receiving therapeutic hypothermia.

Registry
clinicaltrials.gov
Start Date
June 1, 2017
End Date
May 31, 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kyu Nam Park

Professor

Seoul St. Mary's Hospital

Eligibility Criteria

Inclusion Criteria

  • age: 19 years and older
  • underwent TH

Exclusion Criteria

  • Died within 72 h after cardiac arrest
  • Spontaneous or traumatic brain injury
  • Known history of neurological diseases (such as epilepsy)

Outcomes

Primary Outcomes

Comparison of time to normal trace to good neurological outcome evaluated by cerebral performance category (CPC) score 1 to 2

Time Frame: at day 180

Time to normal trace is defined as time to regained normal trace on aEEG after return of spontaneous circulation. The normal trace is defined as continuous cortical activity on the raw EEG scan; in addition, the upper margin of the aEEG scan, referred to as the aEEG maximum, was \>10 uV, and the lower margin of the aEEG scan, referred to as the aEEG minimum, was \>5 uV.

Secondary Outcomes

  • Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)
  • Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5(at day 180)

Study Sites (4)

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