Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265616
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2005-12-13
Brief Title:
Treatment of Refractory Status Epilepticus
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None