Treatment of Refractory Status Epilepticus

Phase 3

Terminated

• Conditions: Status Epilepticus
• Interventions: Drug: thiopental/pentobarbital; Drug: propofol

• Registration Number: NCT00265616
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-15
• Study Start: 2006-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2010-10-27
• Results First Submitted QC: 2013-02-22
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Results First Posted: 2013-04-04
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	thiopental/pentobarbital	thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
1	propofol	propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined

Primary Outcome Measures

Name	Time	Method
Refractory Status Epilepticus Controlled With First Course of Study Drug	after return of continuous EEG activity (typically after 36 hours - 5 days)	Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome at Day 21	21 days	Return to baseline clinical conditions (i.e.: no new handicap, no death)
Patients With Infectious Complications Requiring Specific Treatment	10 days
Patients With Hypotension Requiring Specific Treatment	10 days
Patients With Propofol Infusion Syndrome	10 days	Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.
Intubation Time in Survivors	Up to 3 months

Trial Locations

Locations (5)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Inselspital; 🇨🇭 Bern, BE, Switzerland

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

CHUV; 🇨🇭 Lausanne, VD, Switzerland