Clinical trial NCT00265616: Treatment of Refractory Status Epilepticus
Official title: A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Status Epilepticus
Keywords: Refractory status epilepticus,
coma-induction,
treatment,
propofol,
barbiturates,
efficacy,
safety.
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2005-12-15
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.

Detailed description: Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.

The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.

Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.

Eligibility criteria: Inclusion Criteria:

* Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.

Exclusion Criteria:

* Age \< 16 years old.
* Known pregnancy.
* Cerebral anoxia as SE etiology.
* Epilepsia partialis continua (simple partial SE).
* Known intolerance to the study drugs.
* Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.

Primary outcomes:
measure: Refractory Status Epilepticus Controlled With First Course of Study Drug
timeFrame: after return of continuous EEG activity (typically after 36 hours - 5 days)
Secondary outcomes:
measure: Clinical Outcome at Day 21
timeFrame: 21 days
measure: Patients With Infectious Complications Requiring Specific Treatment
timeFrame: 10 days
measure: Patients With Hypotension Requiring Specific Treatment
timeFrame: 10 days
measure: Patients With Propofol Infusion Syndrome
timeFrame: 10 days
measure: Intubation Time in Survivors
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Bern
country: Switzerland
facility: Inselspital
state: BE
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: BrighamHospital/CHUV
name: Andrea O. Rossetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossetti AO, Milligan TA, Vulliemoz S, Michaelides C, Bertschi M, Lee JW. A randomized trial for the treatment of refractory status epilepticus. Neurocrit Care. 2011 Feb;14(1):4-10. doi: 10.1007/s12028-010-9445-z.