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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Status Epilepticus
 Drug: propofol
Drug: thiopental/pentobarbital
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: May 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Pentotal /Thiopentone

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265616

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Switzerland
Inselspital
Bern, BE, Switzerland
CHUV
Lausanne, VD, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Andrea O. Rossetti, MD BrighamHospital/CHUV
  More Information

Publications:

Responsible Party: Andrea O. Rossetti, MD, Dr, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00265616     History of Changes
Other Study ID Numbers: RSE study, protocol#62/06
Study First Received: December 13, 2005
Results First Received: October 27, 2010
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board
Switzerland: Swissmedic

Keywords provided by Brigham and Women's Hospital:
Refractory status epilepticus,
coma-induction,
treatment,
propofol,
 barbiturates,
efficacy,
safety.

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pentobarbital
Propofol
Thiopental
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants

ClinicalTrials.gov processed this record on June 18, 2013