Treatment of Refractory Status Epilepticus

April 2, 2013 updated by: Andrea O. Rossetti, MD, Brigham and Women's Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Hopitaux Universitaires de Geneve
    • BE
      • Bern, BE, Switzerland
        • Inselspital
    • VD
      • Lausanne, VD, Switzerland
        • CHUV
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Drug: propofol
liquid, mg/kg.h, titrated after EEG
Other Names:
  • Disoprivan
Active Comparator: 2
thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Drug: thiopental/pentobarbital
liquid, mg/kg.h, titrated after EEG
Other Names:
  • Pentotal /Thiopentone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractory Status Epilepticus Controlled With First Course of Study Drug
Time Frame: 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)
after return of continuous EEG activity (typically after 36 hours - 5 days)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Andrea O. Rossetti, MD, BrighamHospital/CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 13, 2005

First Submitted That Met QC Criteria

December 13, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 9, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSE study, protocol#62/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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