Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitatio
- Conditions
- epilepsyischemia10014623
- Registration Number
- NL-OMON50403
- Lead Sponsor
- Ziekenhuis Rijnsate
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 171
-Patients after cardiac arrest with suspected postanoxic encephalopathy
-Age 18 years or older
-Continuous EEG with at least eight electrodes started within 24 hours after
cardiac arrest
-Electroencephalographic status epilepticus on continuous EEG*
-Possibility to start treatment within three hours after detection of
electroencephalographic status epilepticus.
*We will use a broad definition of electroencephalographic status epilepticus,
including all epileptiform discharges (spikes, poly spikes, sharp-waves,
sharp-and-slow-wave complexes) at a rate of >= 0.5 Hz, irrespective of their
spatiotemporal evolution, accompanying clinical phenomena, or effects of
anti-epileptic drugs. Rhythmic delta or theta activity will not be included.
For continuous seizure activity, the minimum duration requirement is 30
minutes. Intermittent seizures of 5 minutes and longer, recurring at least
twice, with seizure-free intervals shorter than 60 minutes will also be
included. EEG assessment for inclusion will be left to the discretion of the
treating neurologist or clinical neurophysiologist.
-A known history of another medical condition with limited life expectancy (<6
months)
-Any progressive brain illness, such as a brain tumor or neurodegenerative
disease
-Pre-admission Glasgow Outcome Scale score of 3 or lower
-Reason other than neurological condition to withdraw treatment
-Follow-up impossible due to logistic reasons, for example not living in the
Netherlands
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure will be neurological outcome defined as the score<br /><br>on the Cerebral Performance Category (CPC) at 3 months dichotomized as good<br /><br>(CPC 1-2 = no or moderate neurological disability) and poor (CPC 3-5 = severe<br /><br>disability, coma, or death).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures will include i) mortality; ii) the CPC scores at 6<br /><br>and 12 months; iii) length of stay on the ICU; iv) duration of mechanical<br /><br>ventilation; v) seizure recurrence within one year; vi) quality of life as<br /><br>measured by the Medical Outcomes Study 36-item short-form health survey (SF36)<br /><br>(Ware and Sherbourne, 1992), vii) depression as measured by the Montgomery and<br /><br>Åsberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979), and viii)<br /><br>cognitive functioning as measured by detailed neuropsychological examination<br /><br>after 12 months.</p><br>