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Treatment of Refractory Status Epilepticus

Primary Purpose

Status Epilepticus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
propofol
thiopental/pentobarbital
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus focused on measuring Refractory status epilepticus,, coma-induction,, treatment,, propofol,, barbiturates,, efficacy,, safety.

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Inselspital
  • CHUV
  • Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2005
Last Updated
April 2, 2013
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00265616
Brief Title
Treatment of Refractory Status Epilepticus
Official Title
A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
Refractory status epilepticus,, coma-induction,, treatment,, propofol,, barbiturates,, efficacy,, safety.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Arm Title
2
Arm Type
Active Comparator
Arm Description
thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Disoprivan
Intervention Description
liquid, mg/kg.h, titrated after EEG
Intervention Type
Drug
Intervention Name(s)
thiopental/pentobarbital
Other Intervention Name(s)
Pentotal /Thiopentone
Intervention Description
liquid, mg/kg.h, titrated after EEG
Primary Outcome Measure Information:
Title
Refractory Status Epilepticus Controlled With First Course of Study Drug
Description
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
Time Frame
after return of continuous EEG activity (typically after 36 hours - 5 days)
Secondary Outcome Measure Information:
Title
Clinical Outcome at Day 21
Description
Return to baseline clinical conditions (i.e.: no new handicap, no death)
Time Frame
21 days
Title
Patients With Infectious Complications Requiring Specific Treatment
Time Frame
10 days
Title
Patients With Hypotension Requiring Specific Treatment
Time Frame
10 days
Title
Patients With Propofol Infusion Syndrome
Description
Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides.
Time Frame
10 days
Title
Intubation Time in Survivors
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea O. Rossetti, MD
Organizational Affiliation
BrighamHospital/CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Inselspital
City
Bern
State/Province
BE
Country
Switzerland
Facility Name
CHUV
City
Lausanne
State/Province
VD
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20878265
Citation
Rossetti AO, Milligan TA, Vulliemoz 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.
Results Reference
result

Learn more about this trial

Treatment of Refractory Status Epilepticus

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