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Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation

Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation - TELSTAR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50403
Enrollment
167
Registered
2013-12-11
Start date
2014-05-08
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy ischemia

Interventions

Treatment of electroencephalographic status epilepticus will be based on international guidelines for treatment of overt status epilepticus. The objective of the treatment will be to suppress all ep

Sponsors

Ziekenhuis Rijnsate
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -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.

Exclusion criteria

Exclusion criteria: -A known history of another medical condition with limited life expectancy (

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be neurological outcome defined as the score on the Cerebral Performance Category (CPC) at 3 months dichotomized as good (CPC 1-2 = no or moderate neurological disability) and poor (CPC 3-5 = severe disability, coma, or death).

Secondary

MeasureTime frame
Secondary outcome measures will include i) mortality; ii) the CPC scores at 6 and 12 months; iii) length of stay on the ICU; iv) duration of mechanical ventilation; v) seizure recurrence within one year; vi) quality of life as measured by the Medical Outcomes Study 36-item short-form health survey (SF36) (Ware and Sherbourne, 1992), vii) depression as measured by the Montgomery and Åsberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979), and viii) cognitive functioning as measured by detailed neuropsychological examination after 12 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)