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Treatment of Refractory Status Epilepticus

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Andrea O. Rossetti, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00265616
First received: December 13, 2005
Last updated: April 2, 2013
Last verified: April 2013

December 13, 2005
April 2, 2013
May 2006
March 2010   (final data collection date for primary outcome measure)
Refractory Status Epilepticus Controlled With First Course of Study Drug [ Time Frame: after return of continuous EEG activity (typically after 36 hours - 5 days) ] [ Designated as safety issue: No ]
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
Proportion of patients with clinical and electrographical control of status epilepticus.
Complete list of historical versions of study NCT00265616 on ClinicalTrials.gov Archive Site
  • Clinical Outcome at Day 21 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Return to baseline clinical conditions (i.e.: no new handicap, no death)
  • Patients With Infectious Complications Requiring Specific Treatment [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Patients With Hypotension Requiring Specific Treatment [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Patients With Propofol Infusion Syndrome [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.
  • Intubation Time in Survivors [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • · Clinical outcome at day 21, assessed by a functional score,
  • · Time of ventilator treatment in survivors,
  • · Incidence of thromboembolism ,
  • · Incidence of infectious complications requiring specific treatment ,
  • · Incidence of hypotension requiring specific treatment ,
  • · Incidence of propofol infusion syndrome.
Not Provided
Not Provided
 
Treatment of Refractory Status Epilepticus
A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Status Epilepticus
  • Drug: propofol
    liquid, mg/kg.h, titrated after EEG
    Other Name: Disoprivan
  • Drug: thiopental/pentobarbital
    liquid, mg/kg.h, titrated after EEG
    Other Name: Pentotal /Thiopentone
  • Active Comparator: 1
    propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
    Intervention: Drug: propofol
  • Active Comparator: 2
    thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
    Intervention: Drug: thiopental/pentobarbital
Rossetti AO, Milligan TA, Vulliémoz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Switzerland
 
NCT00265616
RSE study, protocol#62/06
Yes
Andrea O. Rossetti, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Andrea O. Rossetti, MD BrighamHospital/CHUV
Brigham and Women's Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP