Clinical Trial: Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Seoul St. Mary's Hospital

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison of time to normal trace to poor neurological outcome evaluated by CPC score 3 to 5 [ 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.

  • Comparison of unfavorable aEEG patterns to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]

    Unfavorable aEEG patterns include flat trace (FT), burst-suppression (BS) and status epilepticus (SE).

    FT is defined as isoelectric activity. BS is defined as the virtual absence of activity (<2uV) between bursts of high voltage (>25 uV).

    SE was defined as repetitive epileptiform discharges with amplitudes >50 uV and a median frequency 1 Hz for >30 min.

  • Comparison of diffusion weighted image (DWI) to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]
  • Comparison of the levels of serum neuron specific enolase (NSE) to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]
  • Comparison of convulsive movement and electrical status epilepticus (SE) to poor neurological outcome evaluated by CPC score 3 to 5 [ Time Frame: at day 180 ]


Original Secondary Outcome: Same as current

Information By: Seoul St. Mary's Hospital

Dates:
Date Received: May 7, 2017
Date Started: June 1, 2017
Date Completion: May 31, 2020
Last Updated: May 14, 2017
Last Verified: May 2017