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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00265616 |
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Date of registration:
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13/12/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Refractory Status Epilepticus
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Scientific title:
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A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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23 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00265616 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Switzerland
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United States
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Contacts
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Name:
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Andrea O. Rossetti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BrighamHospital/CHUV |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Status Epilepticus
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Intervention(s)
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Drug: propofol
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Drug: thiopental/pentobarbital
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Primary Outcome(s)
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Refractory Status Epilepticus Controlled With First Course of Study Drug
[Time Frame: after return of continuous EEG activity (typically after 36 hours - 5 days)]
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Secondary Outcome(s)
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Patients With Propofol Infusion Syndrome
[Time Frame: 10 days]
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Intubation Time in Survivors
[Time Frame: Up to 3 months]
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Clinical Outcome at Day 21
[Time Frame: 21 days]
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Patients With Infectious Complications Requiring Specific Treatment
[Time Frame: 10 days]
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Patients With Hypotension Requiring Specific Treatment
[Time Frame: 10 days]
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Secondary ID(s)
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RSE study, protocol#62/06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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