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Insufficient recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined |
|
| 2 | Active Comparator | thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | liquid, mg/kg.h, titrated after EEG |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Refractory Status Epilepticus Controlled With First Course of Study Drug | Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no) | after return of continuous EEG activity (typically after 36 hours - 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome at Day 21 | Return to baseline clinical conditions (i.e.: no new handicap, no death) | 21 days |
| Patients With Infectious Complications Requiring Specific Treatment | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea O. Rossetti, MD | BrighamHospital/CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20878265 | Result | 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. |
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Rcruitment in participating centers took part between 2006 and 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined. |
| FG001 | Thiopental/Pentobarbital | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG) |
| BG001 | Thiopental/Pentobarbital | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Clinical Outcome at Day 21 | Return to baseline clinical conditions (i.e.: no new handicap, no death) | Posted | Number | participants | 21 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| propofol infusion syndrome (non fatal) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrea O. Rossetti | CHUV Lausanne | +41 21 314 1190 | andrea.rosseti@chuv.ch |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D013874 | Thiopental |
| D010424 | Pentobarbital |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| thiopental/pentobarbital | Drug | liquid, mg/kg.h, titrated after EEG |
|
|
| Patients With Hypotension Requiring Specific Treatment | 10 days |
| Patients With Propofol Infusion Syndrome | Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides. | 10 days |
| Intubation Time in Survivors | Up to 3 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Inselspital | Bern | Canton of Bern | Switzerland |
| CHUV | Lausanne | Canton of Vaud | Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Patients With Infectious Complications Requiring Specific Treatment | Posted | Number | participants | 10 days |
|
|
|
|
| Secondary | Patients With Hypotension Requiring Specific Treatment | Posted | Number | participants | 10 days |
|
|
|
|
| Secondary | Patients With Propofol Infusion Syndrome | Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides. | Posted | Number | participants | 10 days |
|
|
|
| Primary | Refractory Status Epilepticus Controlled With First Course of Study Drug | Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no) | Number of patients fulfilling primary outcome criteria | Posted | Number | participants | after return of continuous EEG activity (typically after 36 hours - 5 days) |
|
|
|
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| Secondary | Intubation Time in Survivors | Posted | Median | Full Range | days | Up to 3 months |
|
|
|
|
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | Thiopental/Pentobarbital | titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG) | 1 | 9 | 0 | 9 |
| paralytic ileus (fatal) | Gastrointestinal disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013858 | Thiobarbiturates |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |