Treatment of Refractory Status Epilepticus

Status Epilepticus Clinical Trial

Official title:

A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00265616
• Other study ID #: RSE study, protocol#62/06
• Status: Terminated
• Phase: Phase 3
• First received: December 13, 2005
• Last updated: April 2, 2013
• Start date: May 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2013
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Status Epilepticus

Intervention

Drug:
• propofol
liquid, mg/kg.h, titrated after EEG
• thiopental/pentobarbital
liquid, mg/kg.h, titrated after EEG

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern	BE
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	CHUV	Lausanne	VD
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Countries where clinical trial is conducted

United States,  Switzerland, 

References & Publications (1)

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. doi: 10.1007/s12028-010-9445-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	after return of continuous EEG activity (typically after 36 hours - 5 days)	No
Secondary	Clinical Outcome at Day 21	Return to baseline clinical conditions (i.e.: no new handicap, no death)	21 days	No
Secondary	Patients With Infectious Complications Requiring Specific Treatment		10 days	Yes
Secondary	Patients With Hypotension Requiring Specific Treatment		10 days	Yes
Secondary	Patients With Propofol Infusion Syndrome	Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.	10 days	Yes
Secondary	Intubation Time in Survivors		Up to 3 months	Yes